Pharma Company Seeks Approval For COVID Drug Candidate Molnupiravir
New Delhi: India could have capsules for the treatment of COVID-19 patients subject to the approval of the Central Drugs Standard Control Organisation (CDSCO). Hyderabad-based Natco Pharma Limited has applied to CDSCO for approval of Phase-III clinical trial of Molnupiravir capsules. The capsule has been developed by American pharma major Merck along with Ridgeback Biotherapeutics, ‘mint’ reported.
The company is ready to launch the product this month if approval is given.
According to a press release from the Hyderabad-based pharma company, 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,” it said.
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 that a patient with an immediately life-threatening condition can gain access to the drug.
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.
What is Molnupiravir?
It was originally used in treating Hepatitis B and C, and is administered in a single dose subcutaneous regimen.
When administered early in treating COVID patients, Virafin can help faster recovery and avoid much of the complications, the company said.
It will be available on the prescription of a medical specialist for use in a hospital and institutional setups, it added.
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