Mylan Secures Regulatory Approval for Remdesivir Lyophilized Powder for Injection 100 mg/vial in India for Restricted Emergency Use in COVID-19 Patients
6 July 2020 - - The Drug Controller General of India (DCGI) has approved Dutch generic and specialty pharmaceutical company Mylan N.V.'s (NASDAQ: MYL) 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 company said.

The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalized 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 INR 4,800, which is more than 80% 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 for compliance with good manufacturing practices.

The company continues 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. The approval by DCGI in India represents the first for Mylan in these 127 markets.

Mylan previously announced a global collaboration agreement with Gilead Sciences for the commercialization 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 tenth medicine licensed to Mylan by Gilead, who signed their first agreement in 2006 for the HIV medicine, tenofovir disoproxil fumarate.

As a leading global pharmaceutical company, Mylan is committed to continue doing its part in support of public health needs.

As the situation around COVID-19 continues to evolve, Mylan's priorities remain protecting the health and safety of its workforce, continuing to produce critically needed medicines, deploying our resources and expertise in the fight against COVID-19 through potential prevention and treatment efforts, and supporting the communities in which we operate.

Remdesivir is an investigational new drug developed by Gilead Sciences. Interim results of two large Phase III clinical trials have demonstrated favourable outcomes with Remdesivir. Based on the results, USFDA granted emergency use authorization of Remdesivir to treat hospitalized patients with severe COVID-19 in the US.

In addition, it is recommended for compassionate use in Europe and recently received regulatory approval in Japan, Taiwan and Singapore.