Glenmark's FabiFlu approved for COVID-19 treatment in India

New Delhi: Drug major Glenmark Pharmaceuticals has become the first Indian company to commercially launch an antiviral drug - Favipiravir with brand name FabiFlu - for the treatment of mild to moderate COVID-19 patients.

The company received marketing and manufacturing approval from the Indian drug regulator, Drug Controller General of India (DCGI) and launched the product in the Indian market.

Priced at Rs 3,500 for a pack of 34 tablets (Rs 103 per tablet), the dosage is 200 mg X 9 tablets on the day one and 200 mg X 4 tablets a day for 14 days of the treatment.

Glenmark did a clinical trial among 90 mild and 60 moderate COVID-19 patients across 11 sites in India. The drug is claimed to have an efficacy of over 80% in the treatment of COVID-19 mild to moderate patients.

Sources said Delhi-based Brinton Pharmaceuticals, Bengaluru-based Strides Pharma, Mumbai-based Lasa Supergenerics, Hyderabad-based Optimus Pharma are some of the other Indian firms that have applied for approval and are readying its launch in India.

Glenmark had developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu through in-house R&D. The DCGI allowed fast track trials with Phase III in limited patients. The approval process is also under Emergency Use Authorisation (EUA).

Glenmark will work with the government and medical community to make it quickly accessible to patients across the country," said Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals.

The drug acts by getting into cells and inhibit 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, said the company sources. Asianet Online