quinta-feira, junho 23, 2005

Tipranavir aprovado pela FDA

Aptivus(r) (tipranavir) was approved yesterday by the FDA for the treatment of HIV-positive adults with evidence of viral replication, who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors.

Boehringer Ingelheim issued this Press Release today:
Ridgefield, CT - June 23, 2005 - Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Aptivus (tipranavir) capsules. Accelerated approval is a regulatory process that expedites the approval of therapies for serious or life-threatening illnesses that provide meaningful benefit to patients over existing treatments.

This approval is based on 24-week data from ongoing studies. Longer term data will be needed before FDA can consider traditional approval for APTIVUS. There are no study results demonstrating the effect of APTIVUS on clinical progression of HIV-1.

The approved dose of APTIVUS is 500 mg taken with 200 mg of ritonavir (APTIVUS/r), twice daily. APTIVUS must be co-administered with ritonavir to boost the therapeutic levels of APTIVUS; otherwise, levels of APTIVUS will be insufficient to inhibit HIV replication. APTIVUS/r must be taken in combination with other anti-HIV medications. APTIVUS 250 mg soft gel capsules will begin to be available in pharmacies nationwide within two weeks of FDA approval.

APTIVUS is a non-peptidic protease inhibitor that works by inhibiting protease, an enzyme needed to complete the HIV replication process. APTIVUS is able to enter infected immune cells and inhibit HIV replication for many strains of HIV that are resistant to other commercially available protease inhibitors (PI).

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