Drugmaker Natco Pharma Limited said on Monday that it has applied to the Central Drugs Standard Control Organization (CDSCO) for approval of phase-3 clinical trial of coronavirus antiviral drug Molnupiravir Capsules for the treatment of COVID-19 patients.
The capsule has been developed by US pharma major Merck along with Ridgeback Biotherapeutics. As per a press release from the Hyderabad-based company, pre-clinical data has proven that Molnupiravir has broad anti-influenza activity, comprising highly potent inhibition of SARS-CoV-2 replication.
“Patients treated with a 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,” the company said in its statement.
NATCO is hoping that CDSCO will give emergency approval to this drug based on “compassionate use” for patients. “Compassionate use” approval is given for investigational drugs so that 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. Shares of Natco Pharma were trading 4.16 per cent higher at Rs 914.35 a piece on BSE.
Zydus Cadila recently received restricted emergency use approval (EUA) from DCGI (Drugs Controller General of India) for the use of the antiviral drug ‘Virafin’. The pharma company said that a single dose of antiviral administered subcutaneously early on shows significant clinical and virological improvement in patients with moderate coronavirus. It stated that 91.15 per cent of patients who were treated with the antiviral were RT-PCR negative by Day 7. The treatment also reduces hours of supplemental oxygen in patients.
The company said that when administered early on during COVID-19, the Pegylated Interferon alpha-2b (PegIFN) Virafin will help patients recover faster and avoid many complications. The antiviral will be available on the prescription of medical specialists for use in hospital/institutional setups.