Critical review and analysis of approval of favipiravir for restricted emergency use in mild-to-moderate COVID-19

The Central Drugs Standard Control Organization, the Indian drug regulatory agency, granted accelerated approval to Glenmark Pharmaceuticals to market favipiravir in mild-to-moderate COVID-19 on June 19, 2020, for restricted use. The patients should sign informed consent before receiving favipiravir. Subsequently, Glenmark Pharmaceuticals issued a press release on June 20, 2020, stating that it was a landmark development for COVID-19 patients in India and the approval was backed by strong clinical evidence supporting the use of favipiravir in COVID-19. The authors carefully reviewed the press release issued by Glenmark Pharmaceuticals, product information, and informed consent form available with FabiFlu (R) (Glenmark's favipiravir brand) and public notice issued by the Drugs Controller General of India. They have gone through the regulatory requirements of emergency approvals in India and the USA, WHO's clinical trial synopsis for assessing efficacy of anti-COVID drugs and emergency use authorization granted to remdesivir in the USA. They critically analyzed the efficacy data presented in favor of favipiravir in this due process. Based on the review and analysis, the authors consider that the two crucial publications quoted in the product information, Chen et al. (2020) and Cai et al. (2020), do not provide convincing evidence for the efficacy of favipiravir. The entire clinical data presented in the press release and product information do not offer undisputed support for the efficacy of favipiravir in mild-to-moderate COVID-19. Moreover, it is the right time to take policy decision and frame guidelines on how to handle emergency approvals for medicinal products in grave situations such as the COVID-19 pandemic, in India.