New Drug Innovation 2022

The New Drug Innovation/Medicine Update Blog We Create News related To New Drugs That Using For Day Today Life,  Related New FDA Innovation, Approval, WHO Updates, And Also Discuss About  Medicine Which Is Newly launched In The Market.

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27 July 2020

July 27, 2020

FDA Approval History: Tazverik 2020 New Drug

Approval History of Tazverik


FDA Approved approved Tazverik on 23 January 2020.
Name of brand: Tazverik

Type of dosage: tablets
Generic Name of Tazverik is Tazemetostat
EZM 200 (200 mg tazverik) Pill with EZM 200 imprint is red, round and marked as 200 mg Tazverik. This is manufactured by Epizyme, Inc.


Tazverik is used for epithelioid sarcoma treatment; follicular lymphoma and belongs to the class of medication miscellaneous antineoplastic. Tazverik 200 mg is not a Controlled Substances Act (CSA) drug.

What exactly is TAZVERIK?
TAZVERIK is a generic pharmaceutical drug used for treatment:
Tazverik (tazemetostat) is a methyltransferase inhibitor that is used to treat:
Adults and juvenile patients 16 years of age and older not recommended for complete resection of metastatic or locally advanced epithelioid sarcoma;
Adult patients with relapsed or refractory follicular lymphoma whose tumors are responsive to an EZH2 mutation as identified by an FDA-approved examination and who have undergone at least 2 previous systemic therapies.
Adult patients with follicular lymphoma rebound or refractory who have no appropriate viable treatment choices.
TAZVERIK approval in these patients is based on trials that calculated the percentage of patients following therapy whose tumor shrank or simply disappeared, and how long the reaction lasted. Further validate those advantages, TAZVERIK is still being tested.
It is not known if TAZVERIK would be healthy and successful in children under the age of 16 years.
What is the Advantage of TAZVERIK?
For the 62 TAZVERIK patients, 9 patients (15%) experienced partial or full cancer shrinkage. The shrinkage lasted six months or more for six of these cases (67%).
TAZVERIK has been approved under the accelerated approval plan of the FDA which offers earlier patient access to a potential new medication as the company continues to perform clinical trials to validate and further evaluate the therapeutic value.
IMPORTANT INFORMATION SAFETY :
What's the most important detail about TAZVERIK that I would know?
TAZVERIK can lead to serious side effects including:
Chance of developing new cancers. The rise in new (second) cancers has emerged in people who sought TAZVERIK treatment. Speak to the healthcare professional about the chance to contract new cancer. The health-care professional will check you for new cancers, During/After the TAZVERIK diagnosis. When you feel more exhausted than normal, notify the healthcare provider, or have quick bruising, fever, bone pain, or paleness.

Tell your health care professional about all of your medical problems before taking TAZVERIK, even if you:
Are pregnant or have plans to get pregnant. TAZVERIK has the power to hurt your unborn child. Once you begin therapy with TAZVERIK the health care provider will give you a pregnancy check. When you are pregnant or suspect you might be pregnant, tell the healthcare provider straight away.

Females who may get pregnant will use appropriate non-hormonal birth control (such as condoms) during care and for 6 months after TAZVERIK 's final dosage. Where used during TAZVERIK therapy, birth control pills (oral contraceptives) and other hormonal methods of birth control may not be effective. Talk to the healthcare provider about options for birth control which are best for you.
Males with female partners who are likely to get pregnant will be given adequate fertility control during therapy and for 3 months following the final dose of TAZVERIK.
Are breastfeeding, or are preparing to breastfeed. This is not clear whether TAZVERIK moves into your breast milk. Should not breastfeed during therapy except for one week after the final dose of TAZVERIK.
Inform the healthcare professional about all the medications you are taking, including prescribed and over-the-counter drugs,vitamins and herbal supplements. TAZVERIK can affect the way other medicines function and other medicines that affect the way TAZVERIK works.

What should I avoid during Treatment with TAZVERIK?
During therapy with TAZVERIK, stop consuming grapefruit or drinking grapefruit juice.
Consult to the healthcare provider before taking any new drugs or supplements.

TAZVERIK Dosing:

General Adult Dose for Soft Tissue Sarcoma:
800 mg orally 2 times daily without disease development or excessive toxicity.
Use: For the treatment of adult patients with metastatic or locally advanced epithelioid sarcoma who are not suitable for full resection.

General Pediatric Dose for Soft Tissue Sarcoma:
16 years of age and older:
800 mg orally 2 times daily without disease development or excessive toxicity.
Use: In the care of pediatric patients 16 years of age and over with metastatic or locally advanced epithelioid sarcoma not suitable in full resection.

Indications and Application of Tazverik :
Sarcoma, Epithelioid
Tazverik is recommended for the care of adults and pediatric patients 16 years of age and older with metastatic or locally advanced epithelial sarcoma who are not suitable for full resection.
This diagnosis is approved for accelerated regulation on the basis of an average reaction rate and length of treatment [see Clinical Studies. Continued clearance for this indication may depend on the evaluation and explanation of the clinical advantage in a confirmatory trial(s).

Relapse or Refractory Follicular Lymphoma :
Tazverik is recommended for the treatment of adult patients with relapsed or refractory (R / R) follicular lymphoma (FL) whose tumors are positive for the EZH2 mutation as observed in the FDA-approved study and who have undergone at least 2 previous systemic therapies.
Tazverik is recommended for the treatment of adult patients with R / R FL who do not have appropriate available care choices.
Such indications are approved under accelerated approval on the basis of the average response rate and length of response The continued acceptance of these indications the depend on the evaluation and definition of the clinical advantage in the confirmatory test(s).

Possible side effects of TAZVERIK?
Get emergency medical treatment if you have symptoms of an allergic reaction to Tazverik: hives; trouble breathing; swelling of your face, lips,  tongue, or throat.
Contact your doctor as soon if you have:
The most common side effects of TAZVERIK in people with epithelial sarcoma include:
Stress
sleepiness
Nausea's
Reduced Hunger
Vomiting
Constipation 
The most common side effects of TAZVERIK in patients with follicular lymphoma are:
Tiredness and fatigue
Cold-like signs (upper respiratory infection)
Body Pain
Nausea's
Pain in the stomach (abdominal)
Those are not aware of the potential side effects of TAZVERIK.
Contact the doctor for professional advice on side effects. You should report adverse effects to the FDA at 1-800-FDA-1088.

Drug Drug Interaction of Tazverik?
Sometimes it is not safe to use certain drugs at the same time. Some medications may affect the blood levels of other medicines you take, which can increase side effects or make the treatment less effective.
Certain medicines that interact with tazemetostat, including prescription and over-the-counter medications, vitamins, and herbal products. Tell the doctor of all the existing medications and any drugs you continue or avoid taking. 

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23 July 2020

July 23, 2020

Glenmark: Favipiravir Phase 3 Results 40% Faster Cure From Mild to Moderate COVID-19

Glenmark Announce Top-Line Favipiravir Phase 3 Results in Patients With Led to 40% Faster Cure From Mild to Moderate COVID-19

Phase 3 Trail Demonstrates statistically significant fast time to clinical improvement with favipiravir treatment mild to moderate COVID patients compared to control
  • On Wednesday, Glenmark Pharmaceuticals Ltd announced the top-level findings of its Phase 3 clinical trial for the use of favipiravir in patients with mild to moderate covid-19, suggesting that the treatment resulted in a 40% quicker improvement for patients in terms of symptoms who used the medication compared to those that were still on standard supportive care. 
  • The recovery from symptoms such as temperature, respiratory rate, oxygen saturation and cough relief was the secondary outcome of the 150-patient experiment, while the primary endpoint was the time required to avoid the oral transmission of the virus, which suggests contagiousness of the infected individual. 
  • The tests, which have not yet been peer-reviewed, found that viral clearing was 28.6 % quicker than estimated in the time taken to avoid oral shedding. Glenmark announced that it expects to apply results from the clinical trial for publication in a peer-reviewed journal in the coming weeks. 
  • In terms of secondary endpoints, the organization stated that 69.8% of patients in the favipiravir care arm obtained therapeutic cure by the fourth day, as opposed to 44.9% in the control arm. 
  • The usage of favipiravir often prolonged the initiation of more serious symptoms such as breathlessness, as per the report, with those getting Favipiravir providing a longer median period to first use of oxygen at 5 days and those in the control arm declining in only two days , the company said. 


  • "We are inspired by the top-line findings and these suggest that early diagnosis with favipiravir could enhance health outcomes for mild to moderate patients and may possibly deter patients from advancing to ARDS (acute respiratory distress syndrome) and mortality,"said in a statement by Monika Tandon, Glenmark’s vice president & head of clinical development for global specialty branded portfolio.
  • However, favipiravir usage has contributed to further adverse effects (AEs), with 26 of the 75 patients getting favipiravir having adverse reactions in the control arm versus six patients reporting none. Glenmark said "most AEs have been mild to moderate and none have contributed to medication discontinuation or changes to dose." 
  • The most frequently reported AE has been asymptomatic temporary rises in uric acid, the firm added. Last month, Favipiravir obtained an emergency usage permission from the Somani Central Drugs Quality Cantrol Organization for the treatment of mild to moderate covid-19 after the open-label Phase 3 trial. 
  • However, the organization has faced criticism for not making available the trial results. Legislator of the Nationalist Congress Party Amol Kolhe even claimed that the firm had made misleading statements of its usage in the care of also patients with co-morbid problems such as hypertension and diabetes, and that the medication was overpriced at around 103 rupees per tablet.
  • Glenmark quashed charges in a letter to India's product controller general V.G. Somani on Monday that he made 'fake statements' for the usage of favipiravir and overpricing of the medication. Last wednesday, the firm also cut the price of the medication marketed under the 'FabiFlu' name by 27 % to about 75Rupees Per tablet, which along with it took down the expense of a complete course of 122 tablets to 9,150 for two weeks 
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20 July 2020

July 20, 2020

FDA Approved Tepezza,Approval history of Tepezza In January 21,2020

TEPEZZA
(Teprotumumab)


·       Tepezza:
Tepezza (teprotumumab-trbw) is an entirely human monoclonal antibody and is the target inhibitor of the active thyroid eye disease (AED) insulin-like growth factor 1 (IGF- 1R) receptor.
·        FDA Approved Tepezza In January 21, 2020.
·        Tepezza Is a Brand Name Generic name of Tepezza called teprotumumab-trbw. 
·        Tepezza Is available in Injection Intravenous Dosage Form and it is Manufactured By  Horizon Therapeutics plc Company. 
·        Its Use In Treatment of Eye disease of thyroid.
·      Tepezza Is Use For:
The thyroid eye disorder (sometimes called Grave Eye Disorder) is treated with Tepezza.
Thyroid eye disorders are an infectious disease that affects tissue around the eyes of the immune system. y Symptoms are dry or watery eyes, swollen eye, bulging eyes, skin infections and eye closing problems.
For the reasons not stated in this medicament guide tepezza can be used too.
·      Before Taking Tepezza drug:
Ask the doctor if you have ever had the following:
1.     Inflammatory bowel disease;
2.     Diabetes or hyperglycemia (high blood sugar)
Tepezza can injure an unborn child. Using successful birth control to avoid abortion when you are taking Tepezza and for at least 6 months after the last dose. Ask the doctor if you get pregnant.
This might not be possible to breastfeed when taking this drug. Tell the doctor for any threats.
· How Does Given Tepezza : (Prescribing information)
Tepezza is given as an injection into a vein. The injection will be given to you by the healthcare provider.
Tepezza is usually given once every three weeks for a minimum of 8 doses.
This medication must be administered gradually, and the infusion can take 60 to 90 minutes to complete.
·       Suggested Dosage:
TEPEZZA is prescribed as a 10 mg / kg intravenous infusion with an initial dosage accompanied by a 20 mg / kg intravenous infusion for an further 7 weeks.
Recovery And Planning :
Phase 1: Measure dose(mg) for a 10 or 20 mg / kg dosage depending on the patient weight and decide the number of vials required. The teprotumumab antibody comprises 500 mg of the TEPEZZA vial.
Phase 2: Repeat any TEPEZZA 10mL sterile water vial for injection, USP, using correct aseptic technique. Ensure the diluent stream does not touch the lyophilized material, which has a cakelike appearance. Do not shake the sample, but spin the vial slowly until the lyophilized substance disappears. The recovered solution is 10.5 mL in thickness. Reconstituted solution extract 10.5 mL to receive 500 mg. The final standard is 47.6 mg / mL following reconstitution.
Phase 3: Additional 0.9 percent Sodium Chloride injection, USP, must be dissolved in the restored solution TEPEZZA. A clean syringe and needle will be used to obtain the quantity equal to the volumes of the reconstituted TEPEZZA solution to be inserted in the infusion bag and ensure a steady consistency in the infusion bag. discard the 0.9% Sodium Chloride, USP volume withdrawn.
Phase 4: Reduction of the volume of the TEPEZZA vial(s) restored by weight (kg) of a patient and move to intravenous bag of sodium chloride 0.9 percent of solution, USP for preparing a dilute solution with a minimum volume of 100 mL (under 1800 mg of dose) or 250 mL (for over 1800 mg of dose). Balance the water filtered by gentle reverse.
·        There is no preservative in the drug. For a mixture, the storage time of the reconstituted TEPEZZA solution is 4 hours at room temperatures of 20 ° C to 25 ° C (68 ° F to 77 ° F) or up to 48 hours at cold levels of 2 ° C to 8 ° C (36 ° F to 46 ° F) and the solution is in the container with a dilute comprising 0.9% sodium chloride injection. If chilled before usage, require the distilled solution to reach room temperature before infusion.
·        Parenteral medication items will, if a solution and bottle require, be checked externally for particulate matter and discolouration before administration. TEPEZZA is a colourless or slightly Gray solution that is transparent to opalescent and free from foreign particles. If some particulate matter or discolouration is detected, dump the solution.
·        The recomposed or condensed solution will not freeze.  
·      Side Effects:
When you see signs of an allergic reaction, seek emergency medical help: hives; trouble breathing; swelling of the nose, lips , tongue or throat;
Few side effects can occur after an injection, or after 1.5 hours. When you feel sticky, nervous or out of breath, or whether you have fatigue, chest pain, or rapid heartbeats, notify your caregiver.

          Call the doctor immediately in Case:
1.     Cramping stomach;
2.     Bowel loss control;
3.     A sensation of not emptying the bowels altogether;
4.     Bowel gestures, which abruptly occur;
5.     Bleeding to the rectum;
6.     Diarrhea (in blood or without blood);
7.     Blood Sugar Increased-Higher thirst, increased urination, dry mouth and a fruity scent Breath.
8.     Spasm in the muscles.
9.     Feeling fatigued or faint.
10. Taste change.
11. Dry skin.
Some Common side effects can include the following:
1.     Headache, and fatigue;
2.     Blood sugar high;
3.     Hair Loss;
4.     Diarrhoea; nausea;
5.     Dry skin;
6.     Perception of taste changed.
7.     Spasms in the muscles;
8.     Listening to problems;
WARNING: While this may be uncommon, when taking a drug, certain people can have very unpleasant and even fatal side effects. When you have any of the following signs or symptoms that could be linked to a really bad side effect, tell your doctor or get medical attention right away:
·        Allergic reactions include fever, hives, scratching and redness, bleeding, burning, blistering, or furless eyes, wheezing; stubbornness in the thorn or neck, breathing difficulty, coughing, abnormal hoarseness, or swelling of the mouth, nose , lips, tongue.
·        Signs of elevated blood sugar such as fatigue, sleepiness, nausea, vomiting more frequently, flushing, fast breath, coughing, or breath like fruit-smelling.
·        During or during the injection, injection reactions occurred. Tell your doctor immediately if your pulse, feeling heavy, shortness of breath, body discomfort or symptoms of elevated blood pressure like vomiting, dizziness, falling out, or vision shifts are involved. Notify your doctor immediately.
You May Report At 1-800-332-1088 it can submit side effects to the FDA. You may also record adverse results in https:/www.fda.gov.
·      Cost Of Tepezza :
Tepezza (Teprotumumab) Cost, the company said, cost 14,900 dollars per vial, with full treatments of approximately 23 vials over the course of six months, and the total cost of the wholesale acquisition is $343,000, with an annual net cost of 200,000 dollars.


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08 July 2020

July 08, 2020

New Drug: FDA Approved Ayvakit (avapritinib) Drug 2020


New Drug : Ayvakit
Ayvakit
(avapritinib)

  • FDA Approved: Yes (First approved on 9 January 2020)
  • Name of Brand: Ayvakit
  • Common name: avapritinib
  • Type of dosage: Tablets
  • Manufacturer : Blueprint Medicines Corporation
  • Treatment for: Stromal gastrointestinal tumor. 

Ayvakit:
The kinase inhibitor Ayvakit is the exon-18 mutant gastrointestinal current (GIST) tumor promoter for the treatment of PDGFRα (Platelet-Derived Growth Factor Receptor Alpha ) exones. 
  • Ayvakit is a tablet that is taken from an empty stomach once a day.
  • Ayvakit can cause serious side effects, including bleeding inside the brain, effects on the central nervous system, and injury to a newborn infant. Rare side effects include swelling, nausea , fatigue, difficulty breathing, vomiting, reduced appetite, diarrhea, changes in hair colour, increased tear secretion, stomach pain , constipation, rash and dizziness. 
  • Ayvakit is a prescribed drug used to treat adults with a specific form of cancer of the liver, intestine, or esophagus called gastrointestinal stromal tumor (GIST) that can not be handled through chemotherapy or has spread to certain areas of the body (metastatic) owing to certain defective platelet-derived growth factor alpha (PDGFRA) genes. The health care professional will administer a screening to ensure that you have this rare PDGFRA gene and whether Ayvakit is correct for you. If Ayvakit is safe and effective in children remains unclear.

Instruction Before taking Ayvakit:

Tell your healthcare provider about all of your medical conditions before you start treatment, including if you Are pregnant or plan to get pregnant. Ayvakit will hurt the unborn child.

  • Females in a position to become pregnant:
  • Before you begin treatment, your healthcare provider should do a pregnancy test.
  • Active birth control (contraception) will be used during therapy and for 6 weeks after final dosage. Talk to your healthcare provider about methods of birth control which may be right for you.
  • If you become pregnant or think you may be pregnant during the treatment, tell your healthcare provider immediately.
  • Males with pregnant female partners will use adequate birth control (contraception) during care, including 6 weeks following the final dosage.
  • Are breastfeeding or breastfeeding planned. It is not clear if Ayvakit gets into your breast milk. Should not breastfeed during the procedure, except after the final dosage for at least 2 weeks. Discuss with your health care provider the best way to feed your baby during this time.
  • Asking the health care professional of all the medications you are taking, including over-the-counter and prescribed drugs, minerals, and herbal supplements. Ayvakit may influence how other drugs function, and may change the way Ayvakit operates. Converse with the healthcare professional before beginning a new drug.

How To Take AYVAKIT:

  • Take Ayvakit just as you're instructed by your health care professional to handle it.
  • Do not adjust dosage or avoid taking Ayvakit until you are instructed to do so by your health care professional.
  • If you develop side effects, your healthcare provider may change your dose, stop temporarily or stop treatment with Ayvakit permanently.
  • Take Ayvakit 1x daily.
  • Taking an empty stomach Ayvakit tablet(s) at least 1 hour before, and at least 2 hours after dinner.
  • When you skip an Ayvakit injection, take it as soon as you recall, until the next injection is expected within 8 hours. Take the next dose at regular intervals.
  • If you vomit after taking an Ayvakit dose do not take an additional dose. Perform the next dose at the next planned time.

Avoid This When Taking Ayvakit:

Should not drive or run heavy equipment while you're having doubt or difficulty thinking with Ayvakit during treatment.

Side Effects:

It may cause serious side effects including:

  • Your brain bleeds. Avoid taking Ayvakit and inform your health care provider if you experience any symptoms on one side of your body, such as extreme headache, vision issues, extreme sleepiness, severe fatigue.
  • Effects of the Central Nervous System ( CNS). Ayvakit is common with CNS side effects, and can be severe. Tell your health care provider if you have signs of new or deteriorating CNS, like
  1.  Forgetting
  2.  Trickery
  3.  Perishing
  4.  Tricky thought
  5.  Drought
  6. Schwindles
  7. Sleeping troubles
  8. Term Finding problems
  9.  Seeing things or hearing stuff not present (hallucinations)
  10. Mood change, or behavior change
  • Your health care provider can temporarily stop your medication or reduce the dosage that may help improve your symptoms. If symptoms do not improve, the Ayvakit treatment may be permanently stopped by your health care provider.
The most frequent side effects include: ·
  •          Retaining fluid or swelling
  •          Boredom   
  •        Fatigue
  •          Muscle exhaustion
  •           Spills
  •          Hyperdiarrhea
  •           Lowered appetite
  •          Pain in the stomach (abdominal)
  •          High tearing of the eye
  •          Compulsion
  •          Hurricane
  •          Schwindles
  •          Changes in hair colour

These are not all of Ayvakit's potential side effects. For medical advice on side effects contact the doctor. Side effects can be reported to FDA at 1-800-FDA-1088.

How store Ayvakit?

Place Ayvakit tablets at room temperature between 68 ° F and 77 ° F (20 ° C to 25 ° C).
Keep all medications out of the hands of children and pets.

General Information Use Of Ayvakit:

Drugs are often prescribed for reasons other than those in the patient knowledge leaflet. Do not take this medication for a disease for which it has not been prescribed. Don't give it to others, even if they have the same condition you have. It could harm them. You can ask your health care provider or pharmacist for more information to be provided to health professionals.

Contains Of Ayvakit:

  • Ingredient for successful use: avapritinib
  • Inactive ingredients: copovidone, sodium croscarmellose, stearate by magnesium, and cellulose by microcrystalline.
  • Film coat: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Blue print ink: ammonium hydroxide, black iron oxide, esterified shellac, FD&C blue 1, isopropyl alcohol, n-butyl alcohol, propylene glycol, and titanium dioxide.
DOSE:

Dosage suggested

AYVAKIT 's prescribed dosage is 300 mg orally once daily on an empty stomach, at least 1 hour before and 2 hours after a meal. Continue treatment before initiation of illness or excessive toxicity. Do not make up for the missed dose within 8 hours of the next scheduled dose. If vomiting occurs after AYVAKIT, do not take an additional dose, but proceed with the next scheduled dose.

Concomitant Use of Strong & Modrate CYP3A Inhibitors:

Avoid using AYVAKIT simultaneously with heavy or moderate CYP3A inhibitors. When concurrent use can not be prevented with a mild CYP3A inhibitor, raising the starting dose of AYVAKIT from 300 mg orally once daily to 100 mg orally once daily. to 100 mg orally once daily once daily.
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