Drug firm Glenmark Pharmaceuticals on Tuesday said interim data from its post marketing surveillance study on anti-viral drug favipiravir in India supports its safety and effectiveness in real world settings with no new safety concerns for COVID-19 patients.
The study commenced in July 2020, aimed to evaluate safety and efficacy of favipiravir in mild to moderate COVID-19 patients.
As on date, a total of 1,083 patients have been enrolled in the prospective, open label, multicenter, single arm study, Glenmark said in a regulatory filing.
A total of 13 sites across Mumbai, Bengaluru, Hyderabad, Nashik, Nagpur and Trivandrum took part in the study, it added.
Interim data presented by the company to the regulator reveals no new safety signals or concerns with the use of favipiravir and already-known side effects which were found to be mild in nature, the filing said.
The time to fever resolution was seen on day 3, while two-thirds of the patients achieved clinical cure on day 7.
"It is encouraging to note that our interim data supports the safety and effectiveness of FabiFlu in real-world settings," Glenmark Pharmaceuticals Group Vice President and Head, India Formulations, Alok Malik said.
On June 19, 2020, Glenmark received restricted emergency use approval from India's drug regulator for FabiFlu for the treatment of mild to moderate COVID-19.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.