Tibotec is seeking expanded approval for Prezista (darunavir) to allow first-time treatment takers to use the protease inhibitor (PI), according to a press release from the company issued earlier today. The request submitted to the U.S. Food and Drug Administration (FDA), in the form of a supplemental new drug application (sNDA), includes 48-week data from the phase III ARTEMIS study comparing Norvir (ritonavir)-boosted Prezista to the popular first-line PI option Kaletra in treatment-naive patients.
Prezista received accelerated approval in June 2006, based on 24-week data from clinical trials involving treatment-experienced patients, to expedite access to the drug for people with drug-resistant virus and few antiretroviral options. The sNDA requests full approval from the FDA for both treatment-experienced and treatment-naive patients. The correct dose in treatment-experienced patients is two 300 mg tablets, plus one 100 mg Norvir capsule, twice a day.
Forty-eight week data from the ARTEMIS study were reported earlier this year. According to Dr. Edwin DeJesus, MD, of the Orlando Immunology Center who presented the preliminary results in September, once-daily dosing of Norvir-boosted Prezista—two 400 mg Prezista tablets plus one 100 mg Norvir capsule—combined with Truvada (tenfovir and emtricitabine) “resulted in excellent virologic and immunologic responses” and that it is “well tolerated with a favorable safety profile.” He added that compared with Kaletra, Prezista combined with Norvir “was non-inferior in the overall population, and superior in patients with high viral loads, with a lower incidence of common GI toxicities and triglyceride elevations.”