First Regulatory Approval Granted for Oral Antiviral Favipiravir for Treatment of COVID-19 Patients Gained by Glenmark

June 30, 20200
First approval for favipavir in India – another anti-viral in the COVID-19 treatment arsenal

A fast-tracked manufacturing and marketing approval for Favipiravir was granted to Glenmark Pharmaceuticals by the Drug Controller General of India (DCGI) for restricted emergency use in mild to moderate cases of COVID-19. With this approval, Glenmark’s branch FabiFlu becomes the first oral Favipiravir medication available in India for COVID-19 patients. The company has launched the prescription-based drug at a price of INR 103/tablet.  

The drug has been indicated for treatment of mild to moderately sick patients along with diabetic or cardiovascular comorbidities, showing symptoms of COVID-19. The recommended dose suggested is- 1800 mg twice on the first day, followed by 800 mg twice a day up to day 14. The RNA-dependent RNA polymerase inhibitor, developed by Fujifilm Toyama Chemical was previously approved for treatment of Influenza virus infections in Japan since 2014. Per Glenmark’s press release, the approval is based on interim results from company conducted clinical trials that demonstrated rapid reduction in the viral load within 4 days and clinical improvement of about 88% in the mild to moderate COVID-19 patients.  Glenmark has also disclosed intent to conduct another clinical trial to assess efficacy of combination therapy of antivirals favipiravir and umifenovir in moderate hospitalized adult COVID-19 patients in India.  

Launch of FabiFlu, in India also coincided with the launch of remdesivir generics by Cipla and Hetero. Both these developments have been widely discussed in the media; and have provided hope to the general public in the context of expanding caseloads across metros and hinterland in India. However, multiple medical professionals and public health experts have also expressed their concerns on limited support of clinical data supporting widespread use of these drugs.  In the Glenmark’s favipavir approval, there is no data available in the public domain on trial design to assess statistical rigor of data generated.  The results of the trial has also not been made public yet.    

Favipiravir has been approved in China, Russia and Japan for treatment of seasonal viral flu previously but recently approvals were granted in China, Italy and Russia to treat COVID-19. However, the drug hasn’t received approval yet in the highly regulated markets. Currently the drug is still being researched under numerous clinical trials around the globe. The results presented by trials so far have not been uniform. A study published in the pre-print server medRxiv, evaluating efficacy of favipiravir against umifenovir (Arbidol) in 240 patients presented that neither of the drugs were effective at improving clinical recovery rate of patients.  

Multiple researchers and healthcare professionals across the globe have raised concerns regarding presence of insufficient clinical data to advocate the drug as a treatment alternative to help aid the patients contracting COVID-19.  It is a tight balance in the context of a pandemic where accelerating development of potential solutions is of paramount importance.  We stay hopeful that global stakeholder collaboration results in this objective being finely balanced with rigorous focus on scientific data generation supporting adoption decisions.   

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