Hetero Labs seeks emergency nod for Covid-19 drug Molnupiravir

Hetero Labs, a Hyderabad-based pharmaceutical company, said on Friday that it has sought an emergency use nod from the local regulator for coronavirus disease (Covid-19) drug Molnupiravir, after interim data from a late-stage trial showed that the drug helped in reducing hospitalisations and also speed up the recovery in mildly infected cases of the viral disease, according to news agency Reuters.

Molnupiravir, an experimental oral drug, is being developed by American pharmaceutical companies Merck & Co and Ridgeback Biotherapeutics for treating non-hospitalised Covid-19 patients.

Earlier, Hetero Labs started a phase-III, comparative, randomised and multicentre clinical trial on mildly infected cases. The trial, conducted at dedicated hospitals sites across India, was aimed at evaluating the safety and efficacy of Molnupiravir plus standard of care (test arm) versus standard of care alone (control arm), in mild Covid-19 patients with a positive RT-PCR test and randomised within five days of onset of symptoms, according to PTI.

“Phase 3 Trial Demonstrates Statistically Significant fewer hospital admissions, faster time to clinical improvement and early negative SARS CoV-2 RT PCR with Molnupiravir treatment in mild Covid-19 patients compared to standard of care alone,” Hetero Labs said in a statement.

Hetero Labs also said there was no mortality in both the above groups and adverse events were non serious, mild in severity and none of them led to the discontinuation of Molnupiravir. The most common adverse events which were seen during the trial were diarrhoea, headache and nausea, the company added.

In April, Hetero Labs entered into a ‘non-exclusive licensing agreement’ with MSD (the trade name of Merck & Co.), to produce and supply the drug to India and also to over 100 low-and-middle-income countries.

Apart from Hetero Labs, Merch & Co. also gave license to other Indian drugmakers such as Cipla and Dr Reddy’s Laboratories for the manufacture and supply of the drug.

(With agency inputs)