Gilead Sciences press release
FOSTER CITY, Calif., April 29, 2026 — Gilead Sciences, Inc. today announced the US Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN) – an investigational, once-daily single-tablet combination regimen for the treatment of HIV in adults who are virologically suppressed. The FDA has granted priority review of the application and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 27, 2026.
If approved, BIC/LEN has the potential to be a single-tablet regimen designed to provide sustained virologic suppression with a high barrier to resistance for people living with HIV who are virologically suppressed, including those who are aging, with comorbidities, seeking to streamline a complex regimen, with prior ARV resistance, and those seeking novel treatment options.
Read the full press release here.
Source : Gilead Sciences
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