COVID-19: Glenmark becomes the first pharmaceutical company in India to receive regulatory approval
- Glenmark becomes the first pharmaceutical company in India to receive regulatory approval for oral antiviral Favipiravir, for the treatment of mild to moderate COVID-19
- Manufacturing and marketing approval granted as part of the accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India
- The approval’s restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation
- Favipiravir shows clinical improvements of up to 88% in COVID-19, with a rapid reduction in viral load by 4 days
- Clinical improvement noted across age groups 20 to >90 years, including in patients with co-morbid conditions like diabetes and heart disease suffering from mild to moderate COVID-19
- Glenmark to market the antiviral under the brand name ‘FabiFlu®’
Favipiravir is backed by strong 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.3 It offers a rapid reduction in viral load within 4 days1,4 and provides faster symptomatic and radiological improvement.1,4,5 Of most importance, Favipiravir has shown clinical improvement of up to 88% in COVID-19 mild to moderate COVID 19 cases.3
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 a 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.
Commenting on the significance of this development, Mr. Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd., said, “This approval comes at a time when cases in India are spiraling like never before, putting 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.”
Favipiravir has been 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 adults COVID-19 patients in India.
