Glenmark Pharmaceuticals has got the approval to manufacture and market the antiviral drug, to treat mild Covid-19 cases
In a first, India based Glenmark Pharmaceuticals has got the approval from Drug Controller General of India (DCGI) to manufacture and market the antiviral drug, ‘Favipiravir’, with brand name ‘FabiFlu’, for treating mild to moderate cases of Coronavirus (COVID-19).
The drug was launched soon after the company got the approval late afternoon today, i.e., Saturday, June 20, 2020.
A pack of 34 tablets is available at a price of Rs. 3,500/-. The cost per tablet is Rs. 103/-. The dosage of the drug includes 200 mg of 9 tablets on day 1 and 200 mg of 4 tablets from day 2 to day 14.
The clinical trial was carried out on 90 mild and 60 moderate patients of COVID-19 across 11 sites. The company claims an efficacy of over 80% in the treatment of COVID-19 mild to moderate patients.
The Active Pharmaceutical Ingredient (API) and the formulation for ‘FabiFlu’ were developed through the in-house Research & Development (R&D). The DCGI allowed fast track trials with Phase III in limited patients. The approval process is also under Emergency Use Authorisation (EUA).
Speaking on the occasion, the Chairman and Managing Director, Glenmark Pharmaceuticals – Glenn Saldanha said, “The approval comes at a time when cases in India are spiralling like never before and putting tremendous pressure on our healthcare system. FabiFlu will reduce this pressure. Glenmark will work with the government and medical community to make it quickly accessible to patients across the country.”
The drug gets into the cells and inhibits the activity of viral replication to reduce the viral load. A high rate of viral replication can be controlled with early use of antiviral drugs. In later stages, viral replication slows down and the body’s violent immune response drives disease to complications and organ failure.
Glenmark is also undertaking a study of combining two anti-viral drugs, Favipiravir (an approved drug for COVID-19 pandemic) and Umifenovir (an approved Influenza drug) for treating the COVID-19 patients. It is to be noted that Favipiravir, sold under the brand name Avigan by Fujifilm Toyama Chemical is being used commercially in the therapeutic management of COVID-19 in Bangladesh and UAE. It is under approval process in Egypt and Jordan and is a part of the treatment protocol in Russia, Japan and Saudi Arabia.
Meanwhile, India recorded highest spike of COVID-19 cases in a day with 14,516 fresh cases and 375 casualties. Maharashtra remains the worst hit State with 1,24,331 cases and 5,893 casualties. In the past 24 hours, it recorded 3,827 fresh cases and 142 casualties. Tamil Nadu, the second most affected State recorded 2,396 fresh cases and 38 casualties, taking the total tally to 56,845 cases and 704 casualties. Delhi is close to Tamil Nadu with 53,116 cases and 2,035 casualties. It recorded 3,137 fresh cases and 66 casualties.
In other developments, Uttar Pradesh (U.P.) recorded 692 fresh cases and West Bengal recorded 441 fresh cases. While Gujarat reported 535 new cases, Andhra Pradesh recorded 491 new cases.
As per the Ministry of Health & Family Welfare (MoHFW), there are 3,95,048 cases of COVID-19 in India and there have been 12,948 casualties.
