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• The tests, which have not yet been peer-reviewed, found that viral clearing was 28.6 % quicker than estimated in the time taken to avoid oral shedding.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