sexta-feira, maio 27, 2005
FDA em vias de aprovar tipranavir
FDA advisory panel says yes to tipranavir (TPV)
The United States Food and Drug Administration’s Antiviral Drugs Advisory Panel voted 11-3 in favour of accelerated approval for the new protease inhibitor tipranavir (Aptivus) after public hearings yesterday in Washington DC.
Tipranavir is being recommended for approval in protease inhibitor-experienced HIV-positive patients, although the final labelling and approval must be decided by the FDA by June 22nd. The panel voted to recommend a twice daily dose of 500mg of tipranavir boosted by 200mg of ritonavir, as studied in phase III trials of the drug.