Natco Tests Compassionate Use Window In India For Merck’s COVID Pill
Merck steps in to seal voluntary licensing deals with five Indian firms
Natco seeks emergency approval in India for investigational therapy molnupiravir, currently being developed by Merck & Co for the treatment of non-hospitalized COVID-19 patients. The firm has linked its request to compassionate use amid a ferocious surge in COVID-19 cases in India, posing a potentially delicate choice for the regulator.
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Merck and Lilly tackle some early challenges before striking voluntary licensing deals for COVID-19 therapies with Indian firms. Data around the use of these drugs in low- and middle-income countries could also potentially make them ‘more acceptable’ elsewhere, experts say.
Eli Lilly responds with baricitinib donation plan and efforts to sew up royalty free voluntary licenses with local Indian firms as challenger Natco seeks a compulsory license for its version of the JAK inhibitor, which it is ready to launch.
MSD India outlines further specifics around the just-announced voluntary licensing deal for molnupiravir with Indian firms, noting an expectation to discuss local data needs with the country’s regulator. All eyes are also on whether non-licensee Natco will stay the course for its application for the investigational antiviral.