Drug Controller General of India (DCGI) has denied normal marketing approval to Indian pharma major Glenmark Pharmaceuticals’s drug FabiFlu, or Favipiravir, an investigational anti-viral drug used in Covid-19 management for mild and moderate patients.
Last week, Glenmark Pharmaceuticals presented the results of the Phase 3 clinical trial before DCGI’s Subject Expert Committee, and requested conversion of conditional restricted emergency approval to normal 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 the 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.
DCGI had earlier asked Glenmark to submit the results of the active post-marketing surveillance study of 1,000 patientsat the earliest for further consideration of any approvals. It was subject to the condition that they should include a sizeable number of government hospitals as study sites.
“Now, the DCGI has now imposed an additional condition on the pharma company for conducting a Phase 4 clinical trial instead of active PMS (post-marketing surveillance) study. The drug watchdog has also asked Glenmark to submit Phase 4 trial protocol within a month,” said the member .
Glenmark has conducted Phase 3 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 when compared to 44.9 per cent in the control group who were 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.