Mylan has announced that the Drug Controller General of India (DCGI) has approved its remdesivir 100 mg/vial for restricted emergency use in India as part of the DCGI’s accelerated approval process to address urgent, unmet needs amid the evolving coronavirus 2019 (COVID-19) pandemic. The drug is approved for the treatment of suspected or laboratory-confirmed incidences of COVID-19 in adults and children hospitalised with severe presentations of the disease. The drug will be launched under the brand name DESREM in India and will be available to patients in July at a price of Rs 4,800, which is, reportedly, over 80 per cent less than the price at which the branded version of this product will be available to governments in the developed world.
Mylan will manufacture remdesivir in India at its injectables facilities that also make products for the US.
Rajiv Malik, President, Mylan said, “Mylan and Gilead Sciences have partnered for many years to make high-quality medicines available to people who need them and have made significant progress to reduce the incidence of infectious diseases, including HIV/AIDS, around the world. We commend Gilead for their continued leadership on this front, and also applaud and are proud to continue partnering with the DCGI for its ongoing efforts to accelerate access to critical medicine for patients with COVID-19 in India.
Rakesh Bamzai, President, India and Emerging Markets, said, “The growing global threat of COVID-19 requires a commitment to action by everyone involved in public health. Mylan is cognisant of its responsibility in fighting this pandemic and will leverage its global resources and capabilities including R&D, regulatory, manufacturing and supply chain while engaging with key stakeholders across the licensed territories to serve the patients in need and further its mission of creating better health for a better world.”
Remdesivir is the tenth medicine licensed to Mylan by Gilead, who signed their first agreement in 2006 for the HIV medicine, tenofovir disoproxil fumarate.