Glenmark developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team
Glenmark Pharmaceuticals on Saturday launched an antiviral drug Favipiravir (brand name FabiFlu®) for the treatment of mild to moderate covid-19 patients.
Favipiravir has shown clinical evidence showing encouraging results in patients with mild to moderate covid-19. 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. It offers rapid reduction in viral load within 4 days and provides faster symptomatic and radiological improvement. Of most importance, Favipiravir has shown clinical improvement of up to 88% in covid-19 mild to moderate covid-19 cases," said the company an official statement.
Glenmark, a research-led, integrated global pharmaceutical company said that it has received manufacturing and marketing approval from India’s drug regulator Drugs Controller General of India (DCGI), making FabiFlu® the first oral Favipiravir-approved medication in India for the treatment of covid-19.
Glenmark developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team.
“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," Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd., said.
Saldanha explained that 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, he said.
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 form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity.
Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu® use. The drug will be available 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.
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.
The total number of covid-19 cases on Saturday crossed 4 lakh mark with a record fresh 15790 cases in last 24 hours taking the total tally to 400034. With an additional 378 deaths the toll cross13026. During the last 24 hours, a total of 9,120 covid-19 patients have been cured. Thus, so far, a total of 2,13,830 patients have been cured of covid-19 taking the recovery rate to 54.13%. Presently, there are 1,68,269 active cases and all are under active medical supervision, the government said in a statement. The number of government labs has been increased to 715 and private labs has been increased to 259 (A total of 974). In the last 24 hours, 1,89,869 samples were tested. The total number of samples tested thus far is 66,16,496, the union health ministry said.