Hetero says antiviral drug aids early recovery of mild patients, seeks EUA

Hyderabad-based Hetero has sought emergency use authorization 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 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 such as 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 Organization (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 one used by DRL in its clinical trial.

In May, another Hyderabad-based firm Natco had said it 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 it has the potential to eliminiate Sarscov-2 from the body within five days.

Hetero had done Phase 3 clinical trials here on 1,218 mild Covid-19 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).