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news.Roche has received FDA approval of a new 500mg film-coated tablet formulation of its HIV protease inhibitor Invirase, designed for use in combination with a small dose of ritonavir and other anti-HIV drugs for the treatment of HIV infection.
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The new formulation of Invirase (saquinavir mesylate), which was approved under a six-month priority FDA review, will reduce pill count for each dose by more than half (from five pills to two, twice-daily) compared to the current formulation of Invirase 200mg capsules.
The approval was based on data that show similar drug levels are achieved with Invirase 500mg tablets and Invirase 200mg capsules when each is administered with low dose ritonavir (100mg), taken with food. The new 500mg formulation requires only four Invirase tablets daily – two in the morning and two in the evening, taken with ritonavir.
Originally approved by the FDA in 1995, the introduction of Invirase as the first HIV protease inhibitor represented a major milestone in the treatment of HIV/AIDS. When first available, the recommended dose required a total of nine Invirase capsules daily – three capsules in the morning, afternoon and evening.
In December 2003, the FDA approved Invirase for use in boosted dosing regimens with ritonavir (1000mg Invirase/100mg ritonavir), which enhances therapeutic blood levels of Invirase and allows for twice-daily dosing.
“Today’s approval is one in a long line of milestones that illustrate the Roche heritage of innovation in HIV,” said Dr Malte Schultz, medical director at Roche. “The new 500mg tablet formulation makes Invirase an attractive option for HIV patients across the treatment spectrum, from those just beginning therapy to those with prior treatment experience.”