Pharma major Lupin on Friday announced the launch of the antiviral drug Molnupiravir in India under the brand name Molnulup for the treatment of COVID-19 adults in the country.
"The drug has been given emergency use authorisation by the Drug Controller General of India (DCGI) for treatment of adult patients with COVID-19, with SpO2 > 93%, and the ones who have a high risk of progression of the disease including hospitalisation," the company said in a statement. Internationally, Molnupiravir is an oral antiviral that has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) for the treatment of mild-to-moderate cases of COVID-19 in adults.
Administered orally, Molnupiravir inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Pre-clinical and clinical data have shown Molnupiravir to be effective against the most common SARSCoV-2 variants including Gamma, Delta, and Mu variants.
Molnupiravir should be initiated as soon as possible after a diagnosis of COVID-19 and within five days of onset of symptoms.
Clinical data points suggest that Molnupiravir may be a gamechanger for the most vulnerable and immunosuppressed patients. This would include factors such as obesity, older age (>60 years), diabetes, or heart diseases, the Mumbai-based company said.
Commenting on the development, Rajeev Sibal, President - India Region Formulations (IRF), Lupin said, "The approval for Molnulup is timely as India is again experiencing an upward spike in COVID-19 incidences. In the past two years since COVID-19 has emerged, there is a need for an oral antiviral medicine that can be prescribed by the Healthcare practitioners and then taken by the patients conveniently at home. Through our strong distribution network, we will make Molnulup readily available at pharmacies Pan India to meet patient demand."
Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East regions
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