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Fosamprenavir. Vertex Pharmaceuticals/GlaxoSmithKline
Amanda H Corbett1, Angela D M Kashuba
1School of Pharmacy, The University of North Carolina Hospitals, Chapel Hill 27514, USA. ahcorbet@email.unc.edu
Current Opinion in Investigational Drugs (London, England : 2000)
|June 11, 2002
Summary
Fosamprenavir, an HIV protease inhibitor prodrug, is in late-stage clinical trials for treating HIV infection. Regulatory filings and market launch were anticipated in 2002, with significant sales projected.
Area of Science:
- Pharmaceutical development
- Antiviral drug research
- HIV/AIDS therapeutics
Background:
- Fosamprenavir is a phosphate ester prodrug of amprenavir, an HIV protease inhibitor.
- Vertex Pharmaceuticals developed fosamprenavir, with GlaxoSmithKline (GSK) leading its development for HIV treatment.
Purpose of the Study:
- To summarize the development status and anticipated regulatory and commercial milestones for fosamprenavir.
Main Methods:
- Review of clinical trial progression (Phase III trials initiated and enrollment status).
- Tracking of regulatory submission timelines (NDA filings in US and EU).
- Monitoring of financial projections and market launch predictions.
Main Results:
- Fosamprenavir was in Phase III clinical trials, with two of three trials having completed enrollment by January 2002.
- Glaxo Wellcome received Fast-track status in December 1999.
- Anticipated New Drug Application (NDA) filings in the US and EU during 2002.
Conclusions:
- Fosamprenavir development progressed towards regulatory submission and potential market launch in 2002.
- The drug showed commercial promise, with projected sales reaching £150 million by 2004.