Saquinavir
FDA approves saquinavir, the first HIV protease inhibitor
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Original prompt & settings (JSON) ↗The FDA finished its review in 3.2 months, and Roche told reporters the medicine would be on pharmacy shelves within 48 hours.
6 December 1995: accelerated approval
The US Food and Drug Administration granted accelerated approval on 6 December 1995 to Hoffmann-La Roche's saquinavir mesylate capsules, marketed as Invirase. Roche had filed the application on 31 August, making the review 3.2 months long.
Saquinavir became the first HIV protease inhibitor approved by the FDA — an authorised attack on a different stage of HIV's life cycle from the nucleoside analogues already on the market.
What the label actually said
The approved indication was treatment of advanced HIV infection in selected patients, in combination with nucleoside-analogue drugs. Monotherapy was not approved.
The FDA's Antiviral Drugs Advisory Committee had recommended accelerated approval on 7 November after reviewing trials resting principally on surrogate markers. Those controlled trials described 936 HIV-infected patients, with CD4-count analyses over 16 weeks.
Verification came ten months later
Accelerated approval required later verification of clinical benefit, and the FDA converted it to traditional approval on 27 September 1996. Ritonavir boosting was a later dosing strategy; ritonavir itself was not approved until March 1996.
The approval landed at the peak of US AIDS mortality: 50,628 deaths among people with AIDS in 1995. CDC reported 21,222 deaths attributed to AIDS in 1997 and 17,047 in 1998, a decline that followed widespread combination therapy rather than any single medicine.
Sources
Researched 23 Aug 2026 6 sources 2 audit passes
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What the sources leave uncertain
- The approval date and indication are directly documented by FDA records.
- Historical mortality sources use related but non-identical measures, including deaths attributed to HIV/AIDS on death certificates and deaths among people reported with AIDS. Exact totals therefore depend on the dataset and later reporting adjustments.
- The major mortality decline followed widespread combination antiretroviral therapy, including several protease inhibitors; it cannot be attributed to saquinavir alone.