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FDA approves Bristol-Myers single capsule therapy for HIV

The FDA has granted approval to a new single capsule formulation of Reyataz, manufactured by Bristol-Myers Squibb, for the treatment of HIV-1 infection in adults as part of combination therapy.

Taken once daily along with ritonavir and food as part of a anti-HIV drug regimen, the Reyataz 300mg single capsule formulation can replace two Reyataz 150mg capsules. The treatment is indicated for patients who have previously received anti-HIV medicines, patients who will be receiving tenofovir disoproxil fumarate and patients who have never taken anti-HIV medicines that require Sustiva as part of their anti-HIV drug regimen.

“With the Reyataz 300mg single capsule formulation approval, Bristol-Myers Squibb now has one pill, once-daily HIV medicine options available in three drug classes, as part of combination therapy,” said Anthony Hooper, president, US Pharmaceuticals, Bristol-Myers Squibb.

Reyataz is an anti-HIV drug that blocks the action of the HIV protease enzyme, which is needed for the virus to multiply. Reyataz has been studied in 48-week trials in both patients who have taken or have never taken anti-HIV medicines.