22 MARIt Saquinavir gains US FDAapprovaI

Saquinavir ['Invirase'; Hoffmann·La Roche] is the first protease inhibitor to be approved in the US for use in combination with currently available nucleoside analogues, such as zidovudine. in individuals with advanced mv infection. 'This is some o/the most hopeful news in years/or people living with AIDS', said Donna ShalaJa. Secretary of the Department of Health and Human Services in the US.

Saquinavir is expected to be approved in Switzerland in mid-1996, and NDAs have already been filed in the European Union. Australia. New Zealand and Canada, according to Hoffmann-La Roche.

Fastest approval so far The approval of saquinavir was based on data from

clinical trials which show that combination therapy with saquinavir and a nucleoside analogue increases CD4+ cell counts in individuals with HlV infection.

Saquinavir's approval comes only 3 months after the US FDA received the application. This represents 'the fastest approval of any AIDS drug so far', said Dr David Kessler, Commissioner of the US FDA.

The US FDA's Antiviral Drugs AdviSOry Committee urged the full approval of saquinavir, as well as Glaxo Wellcome's lamivudine and Bristol·Myers Squibb's stavudine, in November this year:- Media releases "SulnphamtaJOJ3: 22, J8NUl'J995,- f1XJ3JifJ90

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