Hetero seeks DCGI approval for emergency use authorisation of its new covid drug

Hetero seeks DCGI approval for emergency use authorisation of its new covid drug

Hetero has approached the Drugs Controller General of India for emergency use authorisation for investigational new drug Molnupiravir after a Phase-III clinical trial conducted by the company showed it led to fewer hospital admissions and quicker recovery for mild Covid-19 patients.

Molnupiravir is being developed globally by Merck Sharp & Dohme (MSD), which inhibits the replication of multiple RNA viruses, with demonstrated activity against SARS-CoV-2 in human airway epithelial cell cultures and potential to completely eliminate the virus from the body within five days.

Hetero said its Phase-III trial demonstrated 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.

The interim results of the trial showed that the median time to clinical improvement was as early as eight days in patients who were given Molnupiravir as compared to 12 days in the group that was on standard of care (SOC) alone.

Most common adverse events reported were nausea, diarrhoea and headache which were resolved completely. The company said that all side effects were non-serious , mild and did not lead to drug discontinuation.

Apart from the clinical trial it conducted on mild patients, the company is also undertaking a separate Molnupiravir study on moderate Covid-19 patients that has been approved by the Central Drugs Standard Control Organisation (CDSCO).

The comparative trial was conducted on 1,218 mild Covid-19 patients that had tested positive on RT-PCR within five days of onset of symptoms. The trial was carried out to evaluate the efficacy and safety of Molnupiravir plus SOC (test arm) as against SOC alone (control arm).

Patients in the clinical trial were randomized to receive either Hetero’s Molnupiravir capsules 800 mg (4 x 200 mg) every 12 hours (twice daily) for 5 days along with standard of care as per the Indian Council of Medical Research (ICMR) guidelines or, in the control arm, to receive standard of care alone.

In April this year, Hetero had entered into a non-exclusive licensing agreement with MSD to manufacture and supply Molnupiravir in India and over 100 low and middle-income countries (LMICs).