Glenmark Pharmaceuticals has launched antiviral drug Favipiravir, under the brand name FabiFlu, for the treatment of patients with mild to moderate COVID-19 at a cost of about Rs 103 per tablet. The medicine will be available as a 200 mg tablet at the cost of Rs 3,500 for a strip of 34 tablets, Glenmark Pharmaceuticals said in a press release on Saturday.
Glenmark has received manufacturing and marketing approval from India’s drug regulator, making FabiFlu® the first oral Favipiravir-approved medication in India for the treatment of COVID-19. Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild tomoderate COVID-19.
Commenting on the development, Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd., 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.”
He added, “FabiFlu has demonstrated an encouraging response in mild to moderate COVID-19 patients during clinical trials. Moreover, it 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.”
Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu® use. The drug will beavailable as a prescription-based medication for INR 103/tablet, with recommended dose being 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.
The antiviral offers broad spectrum RNA virus coverage2 with clinical improvement noted across age groups 20 to >90 years.3 Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID 19 symptoms.
Glenmark successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team. Glenmark filed the product for clinical trial with India’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase 3 clinical trial on mild to moderate COVID-19 patients.
Favipiravir is approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It has a unique mechanism of action: it is converted into an active phosphoribosylated for (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity.
Earlier last month, Glenmark also announced that it is conducting another clinical trial to evaluate the efficacy of two antivirals Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India.