J&J’s Symtuza Approved, But Commercial Outlook Uncertain

The first HIV single-tablet regimen anchored by a protease inhibitor, Symtuza’s prospects are challenged by competitors already on the market and treatment guidelines that prefer integrase inhibitor regimens.

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Johnson & Johnson has obtained US approval for the first protease inhibitor-containing single-tablet regimen for HIV, but Symtuza faces cloudy commercial prospects due to US treatment guidelines that prefer regimens anchored by integrase inhibitors and concerns about eventual generic availability of its components.

Symtuza, which combines J&J’s protease inhibitor darunavir (Prezista/Prezcobix) with three agents licensed from HIV leader Gilead Sciences Inc., was approved July 17, roughly two months ahead of an anticipated...

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