Modi Gov. Panel of Experts Rejects Glenmark’s Proposal for COVID-19 Focused Phase 3 Clinical Trials Combining Favipiravir & Dexamethasone

Modi Gov. Panel of Experts Rejects Glenmark’s Proposal for COVID-19 Focused Phase 3 Clinical Trials Combining Favipiravir & Dexamethasone

The Modi government has rejected Glenmark’s proposed Phase 3 clinical trial combining favipiravir with dexamethasone as a potential treatment for COVID-19. While favipiravir, a Japanese antiviral medication has been approved in several countries targeting COVID-19 (including India as an emergency use type of option), dexamethasone was shown to reduce the COVID-19 death rate in severe to critical cases in University of Oxford’s RECOVERY trial. Consequently dexamethasone is part of India’s approved clinical management protocol for COVID-19 and its also recommended by the U.S. National Institutes of Health (NIH).

As recently covered by Himani Chandna with India’s The Print, the panel of experts assembled by Narendra Modi’s government (subject expert committee or SEC) wield considerable power, even over the Drug Controller General of India (DCGI), India’s drug regulatory. The SEC has a strong say in what drugs and treatments should be afforded opportunity for further research in the world’s second most populous country and eight largest economy as measured by total GDP.  The SEC told major India pharmaceutical company, “No Go,” declaring that “the justification presented for use of favipiravir and dexamethasone in all patients of moderate COVID in the test arm is not adequate.”

Favipiravir Approved in India for Pandemic Use

TrialSite has generated numerous articles showcasing the extensive use of favipiravir in India as several generic companies are producing the antiviral product and distributing for treatment against COVID-19. Glenmark’s favipiravir-based product is known as FabiFlu. Verified in Business Insider India, India’s regulator approved of Glenmark’s favipiravir based product to treat mild to moderate COVID-19 back in June. The Hindustan Times also verified the DCGI nod of approval for FabiFlu as the first oral treatment for COVID-19 in India.

Glenmark Proposal Rejected

Given that Dexamethasone is part of India’s approved clinical management protocol (more severe cases) and favipiravir-based products have at least provisional permission (e.g. FabiFlu), Glenmark perhaps thought this request would be a slam dunk. Not so. At a Sept 23 meeting, the Modi government’s subject expert committee (SEC) declared that they wouldn’t allow for such a combination. The comments were captured in meeting minutes uploaded to the Central Drugs Standard Control Organization (CDSO) website. Among other recommendations, the SEC stated, “Justification presented for use of Favipiravir and Dexamethasone in all patients of moderate COVID-19 in test arm is not adequate.”

About Glenmark Pharmaceuticals

With a focus on generic drug products, Glenmark Pharmaceuticals Limited is based in Mumbai, India, and was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer. The founder named the company after his two sons. Initially doing business in India, Russia, and Africa, the company now operates worldwide.