Last Updated on October 31, 2021 by The Health Master
Hyderabad-based Natco Pharma Limited and Hetero have sought marketing authorisation for their anti-Covid drug molnupiravir from the drug regulator, people in the know told ET.
The Subject Expert Committee (SEC) under the drug regulator is likely to take up their applications soon. Natco has conducted Phase III clinical trials of molnupiravir and submitted the trial results to the drug regulator this month.
“We have submitted phase-III clinical trial results of Molnupiravir to DCGI and we are awaiting for their marketing permission,” Natco said in response to an email. “The trial results show that it helps in early recovery of patients,” people quoted above said.
Hetero has also completed phase 3 clinical trials on 1218 mild Covid-19 patients to assess the efficacy and safety of this drug and applied for emergency use authorisation (EUA).
During its clinical trials, the company found fewer hospital admissions in Molnupiravir group compared to standard of care alone. Patients in the clinical trial were randomised to receive Molunipiravir 800 mg every 12 hours for five days.
In the control arm of the study, the patients received only standard of care. An email sent to Hetero did not elicit any response till the press time.
The drug was initially developed by US-based Ridgeback Biotherapeutics, who later partnered with Merck & Co for further development.
Molnupiravir is a new oral treatment for individuals diagnosed with Covid-19 infection. The experimental antiviral drug is also being evaluated by the US FDA for its effectiveness and safety.
The advisory committee of the FDA will meet on November 30 to take up Merck and Ridgeback’s request for granting emergency use authorization (EUA) for molnupiravir to treat mild to moderate Covid-19.
In India, Merck & Co. has signed voluntary licensing agreements with Cipla Ltd, Dr Reddy’s Laboratories, Emcure Pharmaceuticals Ltd, Hetero Labs Ltd and Sun Pharmaceutical Industries Ltd, for allowing the drug to be manufactured and marketed in India.
Natco has not entered into a licensing agreement with Merck.
Molnupiravir inhibits the replication of multiple RNA viruses including Sars-CoV-2. Merck has claimed that the drug has the potential to eliminate Sars-CoV-2 within five days.
On Wednesday, US drug maker MSD and Medicines Patent Pool (MPP) also entered into a voluntary licencing agreement to facilitate affordable global access for molnupiravir. The agreement will help create broad access for molnupiravir use in 105 low- and middle-income countries (LMICs) following appropriate regulatory approvals.
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