U.S. FDA Declines To Approve Gilead’s HIV Treatment On Glass Vial Concerns – Reuters

The logo of Gilead Sciences Inc pharmaceutical company is seen in Oceanside, California, U.S., April 29, 2020. REUTERS/Mike Blake/File Photo

March 1 (Reuters) – Gilead Sciences (GILD.O) said on Tuesday the U.S health regulator had declined to approve its HIV-1 treatment over concerns related to the vials meant for the drug.

The U.S. Food and Drug Administration cited issues related to the compatibility of the drug, lenacapavir, with the proposed borosilicate container vial in a so-called complete response letter.

The issue of compatibility of the vials has been an issue since December, when some trials of the drug were placed on hold by the FDA due to the potential of formation of sub-visible glass particles in the solution of lenacapavir. (https://bit.ly/3hfeXwc)

Reporting by Amruta Khandekar and Leroy Leo in Bengaluru; Editing by Maju Samuel and Sriraj Kalluvila

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