U.S. FDA approves Gilead's Biktarvy triple HIV drug

Reuters Health Information: U.S. FDA approves Gilead's Biktarvy triple HIV drug

U.S. FDA approves Gilead's Biktarvy triple HIV drug

Last Updated: 2018-02-07

By Reuters Staff

(Reuters) - The U.S. Food and Drug Administration on Wednesday approved Biktarvy, Gilead Sciences Inc's once-daily triple-combination tablet for treatment of HIV infection.

Biktarvy combines new integrase inhibitor bictegravir with Descovy, an older medication that combines nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir alafenamide.

The approval helps "set the stage for long-term growth and sustainability of Gilead's core HIV franchise," RBC Capital Markets analyst Brian Abrahams said in a research note.

Biktarvy will compete with GlaxoSmithKline Plc's Triumeq.

The Gilead drug's wholesale price, about $36,000 a year, is in line with current therapies, according to Guggenheim Securities.

The new drug's label includes a boxed warning that use could worsen hepatitis B infection in certain patients.

Wall Street analysts, on average, forecast Biktarvy sales of around $1 billion this year, rising to a peak of nearly $5 billion annually by 2024, according to Thomson Reuters I/B/E/S.

Shares of Gilead, which reported better-than-expected adjusted fourth-quarter profits on Tuesday, were up $3.56, or 4.4%, at $83.94 in late trading on Nasdaq.

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