Glenmark Pharmaceuticals completes PMS study on FabiFlu in India

The pharmaceutical major announced the successful completion of its Post Marketing Surveillance (PMS) study on Favipiravir (FabiFlu) in India.

The Post Marketing Surveillance (PMS) study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 patients. A total of 1,083 patients were enrolled in the prospective, open label, multicentre, single arm study. The results showed no new safety signals or concerns with the use of Favipiravir, and already-known side effects such as weakness, gastritis, diarrhoea, vomiting etc., were found to be mild in nature. The time for fever resolution was 4 days, while time for clinical cure was 7 days.

Glenmark Pharmaceuticals' PMS study is the first and largest post marketing study conducted in India on Favipiravir in mild to moderate COVID-19 patients. On 19 June 2020, Glenmark Pharmaceuticals received the restricted emergency use approval from India's drug regulator for Favipiravir (FabiFlu), making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19. The approval was granted as part of accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India.

Glenmark Pharmaceuticals posted a 20.7% rise in consolidated net profit to Rs 306.53 crore on 27.6% increase in net sales to Rs 2,946 crore in Q1 FY22 over Q1 FY21.

Shares of Glenmark Pharmaceuticals lost 0.38% to Rs 529.55 on BSE. Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across generics, specialty and over-the-counter (OTC) business with operations in over 50 countries.

Powered by Capital Market - Live News