Roche Files Application With FDA for New Invirase Formulation That Would Reduce Daily Dosage to Four Pills
Swiss-based pharmaceutical company Roche on Monday announced it has submitted an application to FDA for a new formulation of its protease inhibitor Invirase, Reuters reports (Reuters, 6/21). The 500 mg Invirase tablets would decrease patients' pill burden from 10 pills daily to four daily, according to a Roche release. The new tablet also is smaller in size than the current 200 mg capsule and is made to be used in a regimen of 1000 mg Invirase with 100 mg ritonavir, according to the release. Dr. Nicholas Bellos, president of Southwest Infectious Disease Associates, who was involved in clinical trials, said, "It is important to develop anti-HIV therapies that are not only potent and well-tolerated but will also improve convenience for patients, which can help to maximize adherence to a treatment regimen" (Roche release, 6/22). Roche said it plans to file an application to market the new formulation in the European Union "within days," Reuters reports (Reuters, 6/21).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.