Following the news that Glenmark Pharmaceuticals has become the first company in India to receive regulatory approval for oral antiviral favipiravir for the treatment of mild to moderate COVID-19;

Prashant Khadayate, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:

“The approval of Glenmark’s ‘FabiFlu’ for emergency restricted use only by the Drug Controller General of India will help India in its fight against COVID-19 treatment as it will lead to early discharge of patients from hospitals. It will further help in reducing the burden on hospitals as the number of confirmed cases continues to rise.

“According to GlobalData’s COVID-19 dashboard, as of 22 June, India had 425,282 confirmed cases and forecasted to reach 1,393,477 cases in a low transmission risk scenario by 02 July 2020. India is now the fourth worst-hit country globally in terms of COVID-19 confirmed cases.

“Japan was supposed to approve the influenza drug Avigan (favipiravir) in May this year for COVID-19 treatment. However, Japan has deferred the drug approval following assessment of the initial results by a third-party panel that it is too early to judge whether the drug works or not. Now, Japan will only approve Avigan following the completion of clinical trials. According to Japanese health minister Katsunobu Kato, clinical study of Avigan will continue through June and beyond. However, Russia’s health ministry has already approved Avifavir (generic favipiravir) based on initial trial results to take control of the worsening COVID-19 situation in the country.

“FabiFlu recommended dose is 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14. Glenmark has priced FabiFlu at INR103 (US$1.36*) per 200 mg tablet. Therefore, the overall cost of the therapy is estimated to be approximately INR12,500 (US$165*) per patient.

“Furthermore, Hyderabad-based Optimus Pharma, Delhi-based Brinton Pharmaceuticals, Bengaluru-based Strides Pharma and Mumbai-based Lasa Supergenerics are in the process of seeking approval for generic favipiravir in India.

“During this COVID-19 outbreak, each country is making decisions in line with its own public health requirements. We can expect more approvals of generic favipiravir in India. It will also increase drug access and make the pricing competitive. Moreover, the majority of the COVID-19 patients fall in mild to moderate stage and favipiravir can be termed as a drug for the masses amid the COVID-19 outbreak.”

*INR to US$ currency conversion