India gears up to develop key COVID-19 drug: Details here
- Author: Ismael Montgomery May 08, 2020,
May 08, 2020, 0:42
Moving forward, coordination on producing the drug will be "critical", the drugmaker says.
Any disruption to the supply chain impacting these scarce raw materials and other manufacturing inputs could reduce the amount of remdesivir produced and increase the time it takes to do so.
Remdesivir was granted emergency use authorization last week by the US Food and Drug Administration for Covid-19, the highly contagious lung disease caused by the new coronavirus, and Gilead filed for fast-track approval in Japan on Monday.
Remdesivir manufacturing relies on "scarce" raw materials that command their own "lengthy" production timelines, Gilead has said.
If approved, remdesivir would be the first therapeutic drug to treat COVID-19 patients in Japan.
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As part of its strategies to accelerate and maximise access to the drug, Gilead said in a release that it is negotiating "long-term voluntary licenses with several generic drugmakers in India and Pakistan" to produce it for developing countries.
O'Day declined to answer questions about whether Gilead plans to eventually profit from the COVID-19 treatment rather than just donate the medicine.
Japan has approved Gilead Sciences Inc's remdesivir as a treatment for COVID-19, the health ministry said on Thursday, making it the country's first officially authorised drug for the coronavirus disease. While the drug is still undergoing clinical trials, some countries like the United States have given emergency approval to use the drug for their critical COVID-19 patients.
Fauci said that results from a randomized placebo controlled trial sponsored by the NIAID showed that remdesivir has a "clear-cut, significant, positive effect in diminishing the time to recovery". At end-April, Pharmamar commenced a clinical trial for the treatment of patients with Covid19.
Following Gilead's emergency FDA authorization, Bangladeshi company Beximco said it planned to produce the medicine for domestic use, Reuters reported.