Hetero seeks emergency use authorisation for Merck's antiviral drug

Clinical trial shows molnupiravir helps in early recovery in non-hospitalised Covid-19 patients

Hyderabad-based Hetero has sought emergency use authorisation from the Indian drug regulator for anti-viral medicine molnupiravir, a Merck & Co drug, which has shown that it helps in early recovery of patients.

Hetero had entered into a non-exclusive licensing agreement with Merck in April this year to manufacture and supply this oral antiviral drug in India and over 100 low and medium income countries (LMICs).

Apart from Hetero, Merck had signed licensing agreements with several other Indian companies including Cipla, Dr Reddy’s Laboratories (DRL), Emcure, Sun Pharma and Torrent Pharma. These five pharma companies had entered into a collaboration agreement in late June to jointly sponsor, supervise and monitor the clinical trial in India.

The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) has said that DRL will conduct the clinical trial using its product, and the other four pharma companies will be required to demonstrate equivalence of their product to the product used by DRL in its clinical trial.

Earlier in May, another Hyderabad-based firm Natco had said it has initiated phase-3 clinical trials of molnupiravir on patients. It had not entered into a licensing agreement with Merck.

Molnupiravir inhibits the replication of multiple RNA viruses including Sars-CoV-2 in human airway epithelial cell cultures and the company claims that it has the potential to eliminiate Sars-CoV-2 from the body within five days.

Hetero had done phase 3 clinical trials here on 1218 mild Covid19 patients to assess the efficacy and safety of this drug. Patients were given Hetero’s molnupiravir capsules (800 mg) every 12 hours for five days along with standard of care according to the Indian Council of Medical Research (ICMR) guidelines. In the control arm of the study, the patients received only standard of care (SOC).

Interim results from the study analyzing 741 Covid19 patients showed early clinical improvement (or a two point decrease in WHO Clinical Progression Scale) in the molnupiravir group. Hetero claimed that the median time to clinical improvement as early as 8 days in Molnupiravir group compared to 12 days in SOC alone group. There were fewer hospital admissions in molnupiravir receiving patients.

“In addition to the above clinical trial studies, Hetero is also undertaking a separate Molnupiravir study on moderate Covid-19 patients approved by CDSCO,” the company said.