Mylan secures regulatory nod for Remdesivir

V Rishi Kumar Hyderabad | Updated on July 06, 2020 Published on July 06, 2020

Mylan will manufacture remdesivir in India at its world-class injectables facilities   -  REUTERS

The drug is approved for restricted emergency use in Covid patients

Mylan NV 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 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 Desertm in India and will be available to patients in July at a price of ₹4,800, which is more than 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 world-class injectables facilities, which also make product for the US and have been inspected by the US Food and Drug Administration (FDA) for compliance with good manufacturing practices. The company continues to work extensively towards expanding emergency use access for patients in the 127 low- and middle-income countries where it is licensed by Gilead Sciences to do so, subject to reviews by national regulatory bodies and the Prequalification Programme of the World Health Organization (WHO). The approval by DCGI in India represents the first for Mylan in these 127 markets.

Mylan President Rajiv Malik 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 cognizant 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.”

Mylan previously announced a global collaboration agreement with Gilead Sciences for the commercialisation of Remdesivir in 127 low- and middle-income countries, including India. Mylan has a long-standing history of partnering with Gilead to tackle key public health issues in India and around the world, beginning with expanding access to high quality, affordable HIV/AIDS antiretrovirals and now extending its partnership to include Covid-19 treatments. Remdesivir is the 10th medicine licensed to Mylan by Gilead, who signed their first agreement in 2006 for the HIV medicine, tenofovir disoproxil fumarate.

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Published on July 06, 2020
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