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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01 July 2020

July 01, 2020

India’s first COVID-19 vaccine COVAXIN,is granted DCGI approval.

COVAXIN India’s first COVID-19 vaccine,is Granted DCGI approval; human trials are expected to begin in July
  • Bharat Biotech has developed the drug. 
  • Human clinical trials are expected to launch in India in July 2020. 
COVAXIN


The first COVID-19 vaccine candidate in India, COVAXIN, was approved by the DCGI drug regulator for phase I & phase II clinical trials in humans. The drug was developed by Bharat Biotech.

  • It has been established in cooperation with the Indian Scientific Research Council (ICMR) and the National Institute of Virology (NIV). NIV, Pune was isolated from the SARS-CoV-2 strain and transferred to Bharat Biotech. 

  • Bharat Biotech has developed and manufactured the Indigenous, Inactivated Vaccine. 

  • A variety of drug makers across the globe are trying to find a coronavirus antidote but no pharmaceutical firm has yet dominated the race. 

  • Earlier Monday, Reuters announced that the Chinese army has been given the green light to use the vaccine candidate COVID-19 developed by its testing unit and CanSino Biologics after clinical trials have proven that it is effective and has demonstrated some efficacy. 

  • Several medications have been tested for their effectiveness against COVID-19, a coronavirus-related disease, but have fallen short. Gilead Sciences' remdesivir has been shown to be effective in minimizing the time spent by sick people in the hospital, but a treatment is yet to be discovered. 

  • COVID-19 has affected more than 10 million people worldwide and killed half a million of them. 

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25 March 2018

March 25, 2018

LUTATHERA (Injection) : Drug Approval History



LUTATHERA 
(Active ingredient: Lutetium 177 Dotate)

Lutathera Approval History


  • Licensed by FDA: Yes (Licensed first on 26 January 2018)
  • Name of Brand:     Lutathera
  • Generic name:       Lutetium Lu 177 dotate
  • Form of dosage:     Injection
  • Company:              Advanced Accelerator Application S.A.
  • Treatment for:       Neuroendocrine Gastroenteropancreatic Tumors. 

  • LUTATHRA:
(lutetium Lu 177 dotatate) is an analog of Lu-177-labeled somatostatin for the treatment of somatostatin receptor-positive neuroendocrine tumors. 

  • Drug Use For?

LUTATHERA is a drug used for the diagnosis of patients who have a particular form of tumor termed a gastroenteropancreatic neuroendocrine tumor (GEP-NET). NETs are unusual cancers that exist in many hormone-producing cells of the body.

 LUTATHERA is designed to treat neuroendocrine tumors of the mouth, esophagus, liver, and intestines that have somatostatin receptors. 

  • How To Use?

LUTATHERA is delivered directly into the bloodstream by a health care practitioner. This is referred to as intravenous or intravenous infusion. Receiving an injection of LUTATHERA takes about 30 minutes.

 LUTATHERA is delivered once every eight weeks with 4 doses in total. 

  • Benefits of this drug?

LUTATHERA increased the amount of time the tumors did not develop after (progression free survival) therapy. 
  • Side Effetcs: 
The following severe adverse reactions are mentioned elsewhere in the labelling.
  • Myelosuppressions
  • Myelodysplastic Syndrome and Leukemia
  • Toxicity of the kidney
  • Hepatotoxicity
  • Neuroendocrin Hormone Depression 

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01 March 2018

March 01, 2018

New Drug : XEPI (ozenoxacin)

:

Xepi 

(ozenoxacin)


Xepi Is Manufactured by: The Medimetricks

The Approbation Status: Approved In December 2017

Additional treatments: Impetige

Therapeutic Use: Dermatology and infectious diseases 


  • Information About Xepi (ozenoxacin) :

Xepi (ozenoxacin) is an antimicrobial-quinolone.

 Xepi is primarily recommended in adult and pediatric patients aged 2 months or older for the prevention of impetigo due to Staphylococcus aureus or Streptococcus pyogenes.

 Xepi shall be supplied as a topical administration ointment. Topically add a thin layer of Xepi to the infected area twice daily for 5 days. For adult and pediatric patients aged 12 years and older, or 2 percent of the total body surface region, the affected region can be up to 100 cm2 and not exceed 100 cm2 for pediatric patients aged less than 12 years. 

  • XEPI Drug For ?

XEPI is a drug used to treat impetigo caused by certain bacteria (Staphylococcus aureus or Streptococcus pyogenes) in patients Two months of age and older.

 Impetigo is a infectious bacterial infection of the skin that occurs mainly in infants. 

  • How To Use ?

XEPI's a cream thing. Apply twice daily for 5 days in a thin layer to the areas of the skin where the impetigo is present. 

  • Benefits of XEPI :

Most patients diagnosed with XEPI improved impetigo signs and symptoms and didn't need extra antimicrobial treatment relative to those infected with placebo cream. 

  • Clinical Results of XEPI :

FDA Approval
Xepi FDA clearance was based on two multi-center, randomised, double-blind , placebo-controlled clinical trials performed in 723 participants two months of age and older with an impaired body surface area of up to 100 cm2 and randomized to Xepi or placebo for participants 2 months to 11 years of age not reaching 2 per cent. Subjects administered Xepi or placebo twice daily for a duration of 5 days.Subjects of active skin illness, skin inflammation, clinical proof of secondary infection, or chronic signs and symptoms of infection ( fever) have been removed from these trials. In both trials, Xepi showed dominance over placebo over pre-specified clinical and bacteriological endpoints when administered topically twice everyday for 5 days. Bacterial performance, described as bacterial eradication or presumed eradication, was observed in 90.8 percent of patients receiving Xepi compared with 69.8 percent of patients receiving placebo (p<0.0001) at the conclusion of therapy. Xepi was found to have outstanding antibacterial activity against s. Aureus and s, guy. Pyogens, including s-resistant methicillin. Aureus, MRSA. .

  • XEPI Side Effects

The negative effects correlated with the use of Xepi can involve, but are not limited to:

  • Rosacea were
  • Seborrheic skin dermatitis

 Adverse reactions (rosacea and seborrheic dermatitis) have been reported in 1 adult patient treated with XEPI who reported dermatitis during trials. 

  • Mechanism of Action:

Xepi is an antifungal quinolone (ozenoxacin). The mechanism of action involves bacterial DNA enzyme, DNA gyrase A and topoisomerase IV inhibitors. Ozenoxacin against the aureus and pyogenes organism have been demonstrated to be bactericidal. 

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31 December 2017

December 31, 2017

RHOPRESSA,FDA Approval History,Netarsudyl ophthalmic solution

RHOPRESSA

(Netarsudil)

  • General Information About Rhopressa :

Rhopressa (netarsudyl ophthalmic solution) is an inhibitor of Rho kinase.


Rhopressa is primarily recommended in patients with open-angle glaucoma or ocular hypertension for reducing elevated intraocular pressure ( IOP). 

Rhopressa is given as an ophthalmic prescribing remedy. The prescribed dose is once everyday in the evening, one reduction in the affected eye(s). When one dosage is missing, the following dosage in the evening will be followed with care. Dosage is not generally handled twice a day, so is not approved. When Rhopressa is to be used simultaneously with other topical ophthalmic drug products to mitigate IOP, each drug product will be given at least 5 minutes apart.

  • FDA approved:     (Approved for first time on 18 December 2017)
  • Name of Brand:    Rhopressa
  • General name:      Netarsudil
  • Form of dosage:   Ophthalmic solution
  • Treatment of:        Glaucoma
  • Manufactured by: Aérie Pharmaceuticals, Inc. 

  • Clinical Research:

FDA Approval

The FDA clearance for Rhopressa was focused on three phase 3 trials, I,II & III Trails. 

Trail I : The study did not reach its primary effectiveness goal by showing non-inferiority of Rhopressa once-daily lowering of IOP relative to twice-daily timolol. Rhopressa showed non-inferiority relative to timolol in patients under 26 millimeters of mercury (mmHg) in the IOP trial at all nine time points measured and numerical dominance over timolol at the plurality of time points measured. 

Trail II :. Rhopressa dosed once daily as well as twice days, reaching its primary effectiveness endpoint indicating non-inferiority along with timolol twice daily. The primary effectiveness outcome tested subjects with baseline IOPs over 20 to below 25 mmHg (millimeters of mercury) in pre-study. Evidence shows a steady lowering of the IOP level over all baseline IOPs and across the 90-day efficacy span. The most frequent adverse effect was hyperemia, which was confirmed to have risen in 35 percent of patients, and was scored as moderate in the Rhopressa once daily arm of the study for 83 percent of patients. 

Trail III : The study reached its primary effectiveness goal showing one-day Rhopressa non-inferiority when opposed to timolol twice daily. Rhopressa also demonstrated non-inferiority relative to timolol at the pre-specified secondary endpoint level from above 20 mmHg to below 27 mmHg, and even below 28 mmHg at a maximum of over 20 mmHg. The efficacy findings showed a significant lowering of IOP over all baseline IOPs in the study, and across the 90-day efficacy duration. 

  • Rhopressa Side Effects:

Adverse effects consistent with using Rhopressa can involve the following but are not limited to: 
  • corneal verticillata
  • conjunctival hemorrhage
  • conjunctival hyperemia
  • instillation site pain

  • Mechanism of Action:
Netarsudil ophthalmic solution is an inhibitor of Rho kinase, which is assumed to suppress IOP by increasing the outflow of aqueous humor by trabecular meshwork. The precise reason behind this is unclear. 

  • Instruction :
  • Use one drop of the affected eye(s) once daily in the evening.
  • If a dosage is missing, the next dosage will be started throughout the evening.
  • To prevent contamination of the solution, avoid enabling the tip of the dropper to touch the skin, external surfaces, fingertips, or some other object. Serious eye injury and resulting vision impairment can result from the use of polluted solutions. 
  • Rhopressa produces benzalkonium chloride and can be consumed through flexible contact lenses. Contact lenses may be withdrawn prior to instillation of Rhopressa and can be reinserted 15 minutes after administration of Rhopressa.
  • If more than one topical ophthalmic drug is used, it should be administered for at least 5 minutes between applications. 
The most frequent side effect is redness in the eyes. Very popular side effects include corneal verticillata, instillation discomfort, and conjunctival bleeding. 

  • Cost Of Rhopressa : 
The Price & Cost of Rhopressa ophthalmic solution 0.02% is around $294 for a supply of 2.5 milliliters.

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12 December 2017

December 12, 2017

MEPSEVII,FDA Approved MPS VII Drug,Vestronidase alfa

MEPSEVII

(Vestronidase alfa-vjbk)


Mepsevii (vestronidase alfa) is used in Mucopolysaccharidosis VII therapy. It is a human recombinant beta-glucuronidase lysosomal.

• Approved FDA:        Mepsevii First approved on 15 November 2017
• Component used in: vestronidase alfa
• Markname:               Mepsevii
• Corporate name:      Ultragenyx Pharmaceutical Inc.
• Dosage type:              Injection
• Treatment for:          Type VII Mucopolysaccharidesis

  • General Information About Mepsevii:

  1. Mepsevii (vestronidase alfavjbk) is an alysosomal beta glucuronidase recombinant To the human. MPS VII is a lysosomal storage disorder induced by an enzyme deficiency named betaglucuronidase, which causes an abnormal concentration of toxic substances in the body's cells. Mepsevii is an enzyme substitution treatment that substitutes and functions the absent enzyme.
  2. Mepsevii is strictly recommended for pediatric and adult patients undergoing Mucopolysaccharidosis VII.
  3. Mepsevii is provided as an intravenous infusion drug. Mepsevii will be given under the guidance of a healthcare provider with the capacity to treat anaphylaxis. Premedication is advised 30 to 60 minutes before the start of the infusion. The prescribed dose of Mepsevii is 4 mg / kg given by intravenous infusion every two weeks. Administer the infusion for nearly 4 hours. Infuse the first 2.5 percent of the total amount in the first hour. After the first hour, increase the infusion rate as tolerated in order to complete the infusion over the next 3 hours in accordance with the recommended rate guidelines.

  • Clinical findings:

Approval by FDA

The safety and efficacy of Mepsevii have been established in the clinical trial and extended access protocols for a total of 23 patients aged 5 months to 25 years. Patients received Mepsevii at doses up to 4 mg / kg once every two weeks for up to 164 weeks. Efficacy was measured mainly by a six-minute walk examination in ten patients who were qualified to administer the task. Upon 24 weeks of care, the mean distance gap from placebo was 18 meters.
Further follow-up for up to 120 weeks indicated continued progress in three cases and recovery in others. Two patients under the Mepsevii Development Program experienced a marked improvement in pulmonary function.

  • Mechanism of Action:


Mepsevii is a lysosomal beta glucuronidase recombinant to humans. Mucopolysaccharidosis VII (MPS VII or Sly syndrome) is a lysosomal disease caused by GUS dysfunction resulting in GAG aggregation in cells in the body resulting in tissue and organ damage to the multisystems. Vestronidase alfa-vjbk is a recombinant version of human GUS and is intended to produce exogenous GUS enzyme for cellular lysosomal absorption. Residues of manose-6-phosphate (M6P) in the oligosaccharide chains allow binding of the enzyme to cell surface receptors, leading to cellular absorption of the enzyme, lysosomal targeting and subsequent catabolism of accumulated GAGs in affected tissues.

  • WHO WAS IN THE CLINICAL TRIALS?


Who have been involved in the clinical trials?



MEPSEVII was approved by the FDA primarily based on evidence from one clinical trial involving 12 patients with mucopolysaccharidosis VII. The experiment was performed at four US locations.


The number of patients involved in the clinical trial is listed in Figure.


Race
Number of Patients
Percentage
White
9
75%
Other/Unknown
3
25%

  • How were the trials designed?


The value of 24 weeks of MEPSEVII therapy was mainly tested by a 6-minute walking test (6MWT) and compared to placebo in 10 patients who were willing to complete the study. The 6MWT measured the distance a patient was able to walk on a flat surface in 6 minutes. An additional follow-up with 6MWT has been conducted for up to 120 weeks.

The benefit and side-effects of MEPSEVII were primarily based on one trial. Patients are randomly assigned to four groups. Three groups of patients received placebo before starting MEPSEVII treatment and one group received MEPSEVII alone. MEPSEVII or placebo were given as intravenous (IV) infusions every two weeks. Neither patients nor healthcare providers knew which treatment had been administered until after the trial had taken place.

  • Side Effects:

Adverse effects consistent with the usage of Mepsevii can, but are not limited to, involve the following:
  • Extravasation of the infusion site
  • Diarrhoea
  • The rash
  • Anaphylaxis;
  • swelling of the infusion site
  • Natural swelling

The Mepsevii brand mark comes with the following warning black box:
Anaphylaxis has happened with Mepsevii as early as the first dosage, so adequate care assistance will be readily accessible when Mepsevii is administered. Observe patients closely before and for 60 minutes after the infusion of Mepsevii. Start the Mepsevii infusion instantly if the patient has anaphylaxis .

  • Prices for Mepsevii :

The price guide is based on the use of the discount card from Drugs.com, which is adopted by the most pharmaceutical companies in the United States. The cost of Mepsevii (2 mg/mL) is around $2,273 for 5 millilitres,depending on the pharmacy you are visiting  supply. Prices are limited to customers paying in cash and do not apply to insurance plans. 

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09 December 2017

December 09, 2017

HEMLIBRA ,FDA-Approved New Drug HEMLIBRA

                          HEMLIBRA 

(Active Ingredient: EMICIZUMAB)

                      

   

  • About HEMLIBRA:

HEMLIBRA (emicizumab) It is approved by FDA as a prophylactic medicine It is used to Reduce the frequency of bleeding episodes in adults and children with hemophilia-A with factor VIII-inhibitors1 It is given once a week subcutaneously (under the skin).
  1.  Its First new FDA approved Drug/Medicine to treat hemophilia-A with Resistor nearly 20 years 
  2.  its First Bispecific monoclonal antibody to treat hemophilia-A with Resistor 
  3.  Main Factor IXA and X in the blood clotting cascade 
  4.  Its Only treatment option for hemophilia-A with Resistor that can be self-administered once weekly by injection subcutaneously Form.

  • Important information to know about HEMLIBRA? 

HEMLIBRA may also cause serious side effects when used withactivated prothrombin complex concentrate (FEIBA). with including thrombotic microangiopathy and blood clots. 

 The Cases of thrombotic microangiopathy & thrombotic events were reported when on average a cumulative amount of 100 U/kg/24 hours of (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis.

  • About Hemophilia-A Inhibitors:

Hemophilia-A is a rare genetic blood disease where faulty blood clotting factor VIII prevents blood from clotting normally. 

It Can cause frequent bleeding, especially into joints & muscles.

  • These bleeds often cause pain
  • It can lead to deformity,chronic swelling, reduced mobility and long term joint damage.
  • Factor VIII therapy is a standard Replacement treatment for people with hemophilia-A, but in some Case, their immune systems recognize this as a foreign Substance & generate the antibodies to attack it. These antibodies is called inhibitors. 
  • Hemophilia occurs more frequently in males than females.


  1. NEARLY20,000 PEOPLE IN THE U.S. HAVE HEMOPHILIA
  2. ABOUT50-60% OF PEOPLE WITH HEMOPHILIA A HAVE A SEVERE FORM OF THE DISORDER.

  • How HEMLIBRA Work (Mechanism of Action)


  • Blood clotting factors activated In each Cell to form a blood clot, or coagulate. These processes are called as the blood coagulation. 
  • HEMLIBRA is bispecific factor IXa- & factor X-directed antibodys designed to activate the natural coagulation & restore the blood clotting process.
  • People who has hemophilia-A do not have enough functional natural protein factor VIII.
  • By replacing the natural activated factor VIII, HEMLIBRA promotes blood clotting.
  • HEMLIBRA is a different type of molecule than activated factor VIII, and is therefore not expected to induce inhibitors or be affected by inhibitors.
  • HEMLIBRA has a long half-life of approximately 4 weeks, which is related to the amount of time the medicine remains active in the body.

  • Efficacy1 HEMLIBRA :  
  • Primary Endpoint


  1. The approval from FDA of HEMLIBRA is based on positive results of Phase III clinical study in adolescents & adults 
  2. In HAVEN-1 studied the total 109 adolescents & adults (12 years) of hemophilia-A with inhibitors, once weekly preventative administration of HEMLIBRA substantially reduced treated bleeds or preventative use of bypassing agents (BPAs)

  • Secondary Endpoints 
Improvement in a bleed with HEMLIBRA prophylaxis compared to no prophylaxis were consistent across all secondary bleed endpoints.


                           WHAT IT TREAT'S

  • HEMLIBRA?

It is a prescription medicine used for routine prophylaxis to reduce the frequency of bleeding episodes in adults & children with hemophilia-A factor VIII inhibitors.
  • Most important information should know about HEMLIBRA?
HEMLIBRA is increases the potential to your blood to clot. Discontinue the prophylactic use of bypassing agents the day before starting of HEMLIBRA prophylaxis. 

 Carefully follow your instructions provided by healthcare providers regarding when to use an on-demand bypassing agent. & the use of scheduled prescribed dose. 
HEMLIBRA may cause the following serious side effects when used with prothrombin complex concentrate (FEIBA).


  • Thrombotic microangiopathy. This is a condition of blood clots and injury to small blood vessels it may cause harm to your brain, kidney & other organs. Get medical help if you have any of the following symptoms occur during or after treatment with HEMLIBRA.

  • nausea or vomiting
  • feeling sick
  • swelling of arms and legs
  • yellowing of skin and eyes
  • decreased urination
  • confusion
  • weakness
  • stomach (abdomen) or back pain

  • Blood clots (thrombotic events). Blood clots may form in blood vessels in leg,arm, lung or head. Get medical help if you have any of these signs or symptoms of blood clots during or after treatment with HEMLIBRA.  

  • numbness in your face
  • eye pain or swelling
  • trouble seeing
  • chest pain or tightness
  • fast heart rate
  • feel faint
  • swelling in arms or legs
  • pain or redness in your arms or legs
  • shortness of breath
  • headache

How should I use HEMLIBRA?


  • Instructions Use of HEMLIBRA

Information on how to prepare and inject a dose of HEMLIBRA, and how to properly dispose used needles and syringes.

HEMLIBRA interfere with laboratory tests that measure how well your blood is clotting & may cause a false reading. Talk to your healthcare provider about how this may affect your care.
  • The most common side effects of HEMLIBRA include:
  1. Redness, 
  2. tenderness
  3. warmth
  4. itching at the site of injection
  5. headache
  6. joint pain..
  • General information about use of HEMLIBRA.
  1. Sometimes Medicines prescribed for purposes other than those listed in a Medication Guide. 
  2. Do not use HEMLIBRA for a condition for which it was not prescribed. 
  3. Do not give HEMLIBRA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about HEMLIBRA that is written for health professionals...
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