DCGI rejects normal marketing approval request for Glenmark’s FabiFlu

Drug Controller General of India (DCGI) has rejected the application of pharma major Glenmark Pharmaceuticals for normal marketing approval of FabiFlu or Favipiravir, an investigational antiviral drug used in Covid-19 management for mild and moderate patients.

Glenmark Pharmaceuticals, last week, presented the results of phase three clinical trial before DCGI's Subject Expert Committee and requested conversion of conditional restricted emergency approval to regular marketing approval of Favipiravir. The drug has been approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. Currently, Glenmark's FabiFlu is under the Restricted Emergency Use clause of DCGI.

"After detailed deliberation, the committee recommended that Restricted Emergency Use approval with various conditions and restriction of the drug should continue," stated a member of the committee.

While a restricted emergency use clause dictates that an informed consent letter of a patient should be taken before administration of the drug, in a typical marketing approval, there is no need for such a consent letter.

A spokesperson from Glenmark said, "We continue to sell the drug according to the restricted emergency approval guidelines and will submit the PMS data within a few months."

DCGI has asked Glenmark to submit the results of the ongoing post-marketing surveillance study of a thousand patients, which was approved on July 6, at the earliest for further consideration of any approvals. It is subject to the condition that they should include a sizable number of government hospitals as study sites.

"Also, DCGI has now imposed an additional condition on other pharma companies who are manufacturing or marketing Favipiravir for conducting a phase four clinical trial instead of active PMS study. The drug watchdog has also asked them to submit Phase four trial protocol within the close to a month," the member said.

Glenmark has conducted phase three trials for the drug on 150 patients. The company also said that 69.8 per cent of those who were given Favipiravir had normalised temperature, oxygen saturation, respiratory rate and cough by the fourth day as compared to 44.9 per cent who achieved these in the same time frame in the control arm, the group that was not given the drug.

Globally, the drug is being tested in close to 20 clinical trials across 3,000 Covid-19 patients, including ongoing trials in the US, Canada, Japan and Italy, a company spokesperson said.

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