Glenmark Pharmaceuticals has received a green signal from the Drug Controller General of India (DCGI) to evaluate the antiviral drug Favipiravir in clinical trials for treating patients infected with CoVID-19. If the test results are positive, then India will be able to avail this medicine in the next four months.
China, USA, United Kingdom, and Italy are conducting clinical trials for these drugs. With the approval of DCGI, India has joined the league of nations. Favipiravir is the first approved coronavirus drug in China, where this virus originated.
Currently, vaccines for the virus are being developed. But the drug will be of immediate help to treat the patients.
Glenmark developed the drug’s Active Pharmaceutical Ingredients (API) and formulations internally. Following the regulatory approval, the new trial will assess the product in CoVID-19 patients with mild to moderate infection.
Around 150 patients will be enrolled for the study. Participants will be given Favipiravir plus standard supportive care or only standard supportive care.
The treatment duration of the trial is a maximum of 14 days and the total study duration will be a maximum of 28 days from randomisation.
“After having successfully developed the API and the formulations through its in-house R&D team, Glenmark is all geared to immediately begin clinical trials for Favipiravir on CoVID-19 patients in India. The clinical trial will let us know the efficacy of this molecule. If they are successful, Favipiravir could become a potential treatment for patients,” Glenmark Pharmaceuticals Global R&D executive vice president Sushrut Kulkarni said.
The reports of all these trials will be conveyed to the DCGI. If they approve, then the drug production will start after getting a green signal from the Food and Drugs Authority (FDA).