GlaxoSmithKline's HIV drugs division ViiV Healthcare said on Saturday that ...
A GlaxoSmithKline logo is seen at the GSK research centre in Stevenage, Britain November 26, 2019. REUTERS/Peter Nicholls
ViiV, in which Pfizer and Shionogi have small stakes, said it received a so-called complete response letter from the FDA in which the regulator questioned the treatment’s chemistry, manufacturing and controls process, but not its safety. The unit of the British drugmaker, which is challenging HIV drug market leader Gilead Sciences, said it will work with the FDA to determine the next steps for the new drug application.The CRL for the Cabenuva injection, containing two active ingredients cabotegravir and Janssen’s rilpivirine, follows U.S. market approval in April for its once-a-day pill Dovato, also a two-drug combination.
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