Oral COVID-19 Antiviral Seeks India's Approval

Hyderabad-based Natco Pharma Limited announced today it has applied to the Central Drugs Standard Control Organization (CDSCO) in India to approve Phase III clinical trial of Molnupiravir Capsules for the treatment of COVID-19 patients.

Molnupiravir (MK-4482, EIDD-2801) is an experimental oral antiviral originally developed to treat influenza. It is an orally active prodrug of the synthetic nucleoside derivative N4-hydroxycytidine and exerts its antiviral action by introducing copying errors during viral RNA replication.

Patients treated with Molnupiravir have 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.

Molnupiravir was originally developed at Emory University in Georgia and was later acquired by Ridgeback Biotherapeutics, which partnered with Merck & Co.

NATCO stated in a press release it '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 confirmed it is ready to launch Molnupiravir this month if approval is given.

Natco Pharma Limited was incorporated in India in 1981 and today has seven manufacturing facilities spread across India with dedicated modern research laboratories, capabilities in New Drug Development.