New Delhi: MSN Labs (MSN) announced today, that they have entered into a royalty free, non-exclusive, voluntary license agreement with Eli Lilly and Company of USA for manufacturing and marketing of baricitinib for COVID-19 in India.
The drug baricitinib has been granted a restricted emergency use approval in India by the Central Drugs Standard Control Organization for emergency use in combination with remdesivir for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
MSN Labs will be launching the product under the brand name BARIDOZ in two strengths 2 mg and 4mg. MSN has developed the active pharmaceutical ingredient and the formulation of baricitinib in its in-house R&D and manufacturing units.
As part of the COVID treatment range, MSN has already launched FAVILOW (Favipiravir) in the strengths of 200mg, 400mg & 800mg and OSELOW (Oseltamivir) as 75 mg capsules.
Baricitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Baricitinib (Olumiant) is approved by FDA for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.
FDA issued an emergency use authorization (EUA) for the drug Baricitinib, in combination with Remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In India, CDSCO has given emergency use approval for the same.
In a clinical trial of hospitalized patients with COVID-19, Baricitinib, in combination with Remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo with Remdesivir. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated. Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19.