Two pharmaceutical companies have sought permission from India’s drug regulator to discontinue the phase III trials of American firm Merck & Co’s experimental antiviral drug molnupiravir in moderate Covid-19 patients, a government document shows, though one of the two manufacturers told News18.com that the “results have come out exceedingly well” in mild cases.
The oral drug molnupiravir has been hailed by many as a “game changer” and is touted to become the first antiviral medicine to treat Covid-19.
Aurobindo Pharma and MSN Laboratories have presented the interim clinical trial data in moderate Covid-19 patients before the subject expert committee (SEC) — the panel that advises the Drug Controller General of India (DCGI) on applications seeking approvals for new drugs, vaccines, and clinical trials in India.
The trials are being done using molnupiravir’s 200 mg and 400 mg capsules.
Moderate vs mild
During the meeting on October 4, both the firms separately stated that “they want to discontinue phase III trial in moderate Covid-19 patients and continue the phase III trial in mild Covid patients”, according to the minutes of the meeting recently uploaded on the Central Drugs Standard Control Organisation (CDSCO) website.
The panel has asked firms to submit the concerns in writing for further consideration.
Molnupiravir came into the spotlight on October 1 when Merck announced that the drug reduced the risk of hospitalisation or death by 50% in an interim trial. Following the promising results, the American pharma company also announced its decision to stop the trials and seek emergency approval from the US drug regulator.
Merck has entered into voluntary licensing agreements with at least eight Indian drug makers, including Cipla, Dr Reddy’s Laboratories, Sun Pharma, Hetero, Emcure Pharmaceuticals, Aurobindo Pharma, and others.
Problems in patient recruitment led to discontinuation: Aurobindo
According to the spokesperson at Aurobindo Pharma, the company has completed the trials for molnupiravir in mild patients as per protocol, and “the results have come out exceedingly well”.
In fact, the company said that “the data has been submitted to the DCGI already”.
“We have also conducted the trials for molnupiravir in 100 moderate patients. We have faced challenges in patient recruitment at this juncture and we are evaluating the further course of action,” the spokesperson said.
A mail sent to Merck and MSN Laboratories did not fetch comments immediately.
Results shown by molnupiravir announced this month by Merck
According to Merck, the interim analysis of the medicine showed that 7.3% of patients who received molnupiravir were hospitalised through 29 days as compared with 14.1% of placebo-treated patients who were hospitalised or died. Placebo is a dummy pill that has no therapeutic effect.
“Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo,” the company said in the release.
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