Favirpiravir yet to find favour with ICMR

New Delhi: Even as DCGI had approved antiviral favipiravir for restricted emergency use to treat mild to moderate Covid-19 patients, the Glenmark Pharma’s drug was not part of the treatment protocol reviewed by the Indian Council of Medical Research last week. “The inclusion of favipiravir was discussed in the meeting on Friday.
However, the experts were not convinced and decided not to put it in the revised treatment protocol,” a person aware of the matter told ET on condition of anonymity.

Earlier in June, the DCGI had granted permission to manufacture and sell Glenmark pharmaceuticals’ Favipiravir for Covid-19. The approval for Favipiravir 200 mg tablet was given following the recommendation of special Subject Expert Committee (SEC) on Covid-19.

The approval came with a caveat that the company will have to submit a copy of the informed consent and report of the ongoing clinical trials within three months. The SEC had also recommended that the drug should be used with caution in patients with a history of abnormalities in metabolism of uric acid.

It also asked the company that post-marketing surveillance should be conducted on the first 1000 patients to assess safety and efficacy of the drug.

Some experts during their meeting on Friday expressed their doubts and decided to wait for the results of another study done by ICMR on Favipiravir.

“The results of the trial done by ICMR are awaited. There was a growing scepticism among some experts regarding Favipiravir,” sources further added.

Public health experts have also questioned the scientific basis of its approval. On June 26 the All India Drugs Action Network (AIDAN) had also written to the DCGI asking about the details about the study carried by Glenmark. “In the case of favipiravir, no information is available about the studies and data submitted by Glenmark for marketing approval. It is so far unclear if Glenmark’s trials have been completed or whether the approval was based on initial or interim results. No trial data by Glenmark have been published to date. Favipiravir is still under trial in many countries and its efficacy in COVID-19 is yet to be proved. In such circumstances, public availability of clinical evidence of safety and efficacy becomes extremely critical,” it said.

Glenmark started Phase III clinical trials of the drug after it received permission from the DCGI in May.

After it got the approval, Glenmark had said that Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19. The antiviral offers broad spectrum RNA virus coverage with clinical improvement noted across age groups 20 to >90 years. Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID 19 symptoms. It also said that the drug offers rapid reduction in viral load within 4 days1,4 and provides faster symptomatic and radiological improvement.1,4,5 Of most importance, Favipiravir has shown clinical improvement of up to 88% in COVID-19 mild to moderate COVID 19 cases.