The SEC seeks details on risk management in case of any adverse events
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he subject expert committee (SEC) of India’s drug regulator has deferred the approval of the much-awaited covid-19 antiviral pill Molnupiravir as clinical trial data from companies remains inconclusive on the efficacy of the drug.
The decision comes a week after the USFDA’s expert panel narrowly recommended it for emergency use authorization (EUA) with a caveat that the nod will be revoked if a better drug comes through.
The Indian SEC asked companies why should they be granted a EUA when the efficacy of the drug is so low. It has asked companies to submit details of a risk mitigation plan in case of an adverse event.
As concerns rise about a potential Omicron wave of covid-19 amid suspicion of waning immunity and vaccines’ capability to fight the new strain, attention has turned to new antiviral drugs that could potentially help treat the infected. Among the top two candidates are Molnupiravir from Merck and Paxlovid from Pfizer.
The trials were conducted by Dr Reddy’s Laboratories (on behalf of Sun Pharmaceuticals Ltd, Cipla Ltd and Emcure Pharmaceuticals Ltd), Optimus Pharma, Aurobindo Pharma, Natco Pharma, Hetero Drugs and BDR Pharmaceuticals. Molnupiravir is an old molecule that was re-purposed for covid-19 by Ridgeback Therapeutics and US-based Merck.
Separately, US drugmaker Pfizer has received approval for its clinical trial protocol to conduct trials for its antiviral drug Paxlovid in India. Pfizer did not respond to a query sent on Sunday evening.
After initial euphoria on the interim results of Molnupiravir, Merck said in November that after all the pooled analysis of a randomized control trial, the relative risk reduction for people who took the drug was 30%, compared to the earlier figure of 50%. The FDA’s subject expert committee voted 13-10 for the nod.
India’s SEC has been watching the US findings and data on co-morbid and at-risk patients before taking a decision, a person aware of the development said on condition of anonymity.
“Our analysis of the trial is consistent with 30-35% improvement within the first five days of the administration," said Srinivasa Reddy, managing director of Optimus Pharma, one of the companies that conducted Molnupiravir clinical trials.
The company said that it has done the trial on patients infected with the Delta variant, but the efficacy against Omicron can only be assessed once the drug is administered among patients.
Mumbai-based BDR Pharma, which has also conducted Molnupiravir clinical trial, said there is enough data on India-specific patients for the SEC to take an informed decision. “Within all the eight companies who conducted the trial, we have a total data of close to 5,000 patients," said Dharmesh Shah, managing director of BDR Pharma. “At the end of the day, so many drugs were hyped for efficacy, but ultimately, we saw clinicians taking a call on its use irrespective of their trial results."
Despite Molnupiravir’s low efficacy, the UK has approved it. Several low and middle-income countries will be watching the SEC’s decision as Indian generic firms will be key suppliers of this drug to countries in Southeast Asia and Africa.
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