Gilead’s potential coronavirus treatment gets FDA’s orphan drug label


FILE PHOTO: A Gilead Sciences, Inc. office is shown in Foster City, California, U.S. May 1, 2018. REUTERS/Stephen Lam

(Reuters) – Gilead Sciences Inc’s experimental drug remdesivir, seen as one of the more promising potential treatments for the coronavirus, on Monday received the orphan drug designation from the U.S. Food and Drug Administration.

The announcement comes days after U.S. President Donald Trump called on the FDA to streamline its approval process for treatments such as remdesivir, which is currently being tested in clinical trials, with results expected as early as next month.

The orphan drug status provides a seven-year market exclusivity period, as well as tax and other incentives for drug companies developing treatments for rare diseases that affect fewer than 200,000 people.

Gilead on Sunday said it was temporarily putting new emergency access to remdesivir on hold due to an exponential increase in so-called compassionate-use requests for the drug.

There are currently no approved treatments or preventive vaccines for COVID-19, the disease caused by the coronavirus. Most patients currently receive only supportive care such as breathing assistance.

Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Sriraj Kalluvila



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