Glenmark approved to supply favipiravir as COVID-19 treatment in India
Indian authorities have given their first approval for the oral antiviral favipiravir for treatment of COVID-19 to Glenmark Pharmaceuticals.
Glenmark Pharmaceuticals has announced that it has become the first pharmaceutical company in India to receive regulatory approval to supply the oral antiviral favipiravir in the country for the treatment of mild to moderate COVID-19.
Glenmark developed the favipiravir active pharmaceutical ingredient (API) and the formulation for its drug through its own inhouse R&D team. It plans to market the antiviral under the brand name FabiFlu®.
When administered, the API is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognised as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity.
The company says that favipiravir shows clinical improvements clinical improvement of up to 88 percent in mild to moderate COVID-19 cases, with rapid reduction in viral load by four days. It can also be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease as long as they have mild to moderate coronavirus symptoms.
According to Glenmark, manufacturing and marketing approval was granted as part of an accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India.
The drug will be available as a prescription-based medication, with the recommended dose being 1,800mg twice daily on day one, followed by 800mg twice daily up to day 14.
Furthermore, the approval’s restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation.
Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals, said: “This approval comes at a time when cases in India are spiralling like never before, putting a tremendous pressure on our healthcare system. We hope the availability of an effective treatment such as FabiFlu® will considerably help assuage this pressure and offer patients in India a much needed and timely therapy option… Moreover, favipiravir is orally administered and so it serves as a more convenient treatment
option over other intravenously administered medications. Glenmark will work closely with the
government and medical community to make FabiFlu® quickly accessible to patients across the country.”