India approves remdesivir for restricted emergency use in COVID-19 patients

The Drug Controller General of India (DCGI) has approved Mylan’s Remdesivir Lyophilised Powder for Injection 100 mg/vial for restricted emergency use as a COVID-19 treatment in India. The approval is part of the DCGI’s accelerated approval process to address urgent, unmet needs amid the pandemic.

The drug has been approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalised with severe symptoms. It will be launched in India under the brand name DESREM™ and will be available to patients in July at a price of INR 4,800. This price is a fifth of what the product will cost governments in the developed world.  

According to the enterprise, it will manufacture remdesivir in India at its world-class injectables facilities, where it will also make product for the US. These facilities have already been inspected by the US Food and Drug Administration (FDA) for compliance with good manufacturing practices.

It also stated that it will continue to work extensively toward 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 Program 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: “Our approval is a significant milestone for Mylan, for the global public health community and, most importantly, for patients who are battling this pandemic. Developing DESREM™ and bringing it to patients in India with such unprecedented speed is a testament to the strength of our global operations and scientific capabilities and our commitment to serving patients who continue to rely on us during this time. We are proud to continue our work in support of public health in partnership with governments and other stakeholders as we work together in the fight against COVID-19.”

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

Remdesivir is an investigational new drug developed by Gilead Sciences and licenced to Mylan for commercialisation in 127 low- and middle-income countries. Interim results of two large Phase III clinical trials have demonstrated Remdesivir has a favourable effect on COVID-19 symptoms. It has been granted emergency use authorization (EUA) to treat hospitalised patients with severe COVID-19 in the US and is recommended for compassionate use in Europe.