Natco seeks approval for phase-3 trial of Molnupiravir for COVID-19 treatment

According to the Hyderabad-based Natco Pharma, pre-clinical data have shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication. Natco is hoping that CDSCO would give emergency approval of this drug based on “compassionate use” for patients.

New Delhi:Drug major Natco Pharma on Monday said it has sought approval from the Central Drugs Standard Control Organization (CDSCO) in India for phase-III clinical trial of Molnupiravir capsules for the treatment of COVID-19 positive patients.

CDSCO is responsible for approval of drugs, conduct of clinical trials, laying down the standards for drugs, control over the quality of imported drugs in the country and coordination of the activities of state drug control organisations.

"Natco Pharma has applied to the Central Drugs Standard Control Organization (CDSCO) in India for approval of phase-III clinical trial of Molnupiravir capsules for the treatment of COVID-19 positive patients," the company said in a regulatory filing.

Natco Pharma said pre-clinical data have shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication.

"Patients treated with Molnupiravir achieved response within five days of therapy indicating that the duration of treatment with Molnupiravir is short, with the additional advantage of being an oral therapy, the company added.

Natco is hoping that CDSCO would give emergency approval of this drug based on “compassionate use” for patients.

“Compassionate use” approval is given for investigational drugs so a patient with an immediately life-threatening condition can gain access to the drug, Natco Pharma said, adding that the company is ready to launch the product this month if approval is given.

Shares of Natco Pharma were trading 4.16 per cent higher at Rs 914.35 apiece on BSE.

(PTI)