Natco Pharma Limited 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.
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 5 days of therapy indicating that the duration of treatment with Molnupiravir is short, with the additional advantage of being an oral therapy.
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. The company is ready to launch the product this month if approval is given.