MORGANTOWN — Mylan announced on Monday that India’s Drug Controller General of India (DCGI) has approved its remdesivir 100 milligram vial for restricted emergency use as part of the DCGI’s accelerated approval process to address urgent, unmet COVID-19 pandemic needs.
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, Mylan said.
Mylan said the drug will be launched under the brand name DESREM and will cost more than 80% less than the price of the branded version available to governments in the developed world.
Mylan will manufacture remdesivir in India at facilities that also make product for the U.S. and have been inspected by the U.S. Food and Drug Administration for compliance with good manufacturing practices, Mylan said.
Mylan said it 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 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.”
Mylan previously announced a global collaboration agreement with Gilead Sciences for the commercialization of remdesivir in 127 low- and middle-income countries, including India. Gilead has signed similar licensing agreements with four other generic pharmaceutical manufacturers based in India and Pakistan.
Remdesivir is an investigational new drug developed by Gilead Sciences. Interim results of two large Phase III clinical trials have demonstrated favorable outcomes, Mylan said. Based on the results, the FDA granted emergency use authorization of remdesivir to treat hospitalized patients with severe COVID-19 in the U.S. In addition, it is recommended for compassionate use in Europe and recently received regulatory approval in Japan, Taiwan and Singapore.
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