Study on FabiFlu supports safety, effectiveness with no new red signals

New Delhi : Glenmark Pharmaceuticals on Tuesday announced its interim data of 503 patients from its Post Marketing Surveillance (PMS) study on Favipiravir in India.The PMS study, commenced in July 2020, aimed to evaluate safety and efficacy of Favipiravir in mild to moderate Covid-19 patients.This PMS is the first and large post marketing study being conducted in India on Favipiravir in mild to moderate Covid-19 patients and as on date, a total of 1,083 patients have been enrolled in the prospective, open label, multicentre, single arm study.A total of 13 sites – both government and private institutions – across Mumbai, Bengaluru, Hyderabad, Nashik, Nagpur, and Thiruvanthapuram took part.Interim data presented by Glenmark to the regulator reveals no new safety signals or concerns with the use of Favipiravir and already-known side effects such as weakness, gastritis, diarrhoea, vomiting etc., which were found to be mild in nature.The time to fever resolution was seen on day 3, while two-third of the patients achieved clinical cure on day 7. The study was conducted in patients with mild to moderate Covid-19, in line with the approved indication of the drug.
The mean age of patients was 40 years, with the most common age group being 30-45 years. Women comprised 40 per cent, while men 60 per cent of the study population. Hypertension and diabetes were the two most common comorbidities noted in these patients. Fever was present in all patients at baseline followed by cough (84.6 per cent), fatigue (55 per cent), and new loss of taste (38.1 per cent).Commenting on these findings, Alok Malik, Group Vice President & Head, India Formulations, said: “It is encouraging to note that our interim data supports the safety and effectiveness of FabiFlu in real-world settings. Since its launch last year, FabiFlu has provided immense relief to millions of patients in India and the world, while also reducing the overall burden on healthcare infrastructure. We will soon submit the final study findings to the regulator and continue to deliver FabiFlu’s multiple benefits to patients all over.”On June 19 2020, Glenmark became the first company in India to receive restricted emergency use approval from India’s drug regulator for 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.