European Commission OKs Novartis' Rasitrio and new label for Bristol-Myers' Reyataz

Following a positive advisory recommendation in September, the European Commission has now approved Swiss drug major Novartis’ (NOVN: VX) Rasitrio, the first triple combination of aliskiren, amlodipine and hydrochlorothiazide (HCT) in a single pill for the treatment of hypertension, the company revealed this morning.

"For the first time, high blood pressure patients in Europe with complex needs will have access to a single pill combining the unique properties of Rasilez with two well-established and effective high blood pressure treatments,” said David Epstein, division head of Novartis Pharmaceuticals, noting that “Rasitrio is the first Rasilez-based triple combination pill available in Europe to help patients requiring multiple medications reach their treatment goal.”

The approval of Rasitrio is based on pivotal Phase III data involving more than 1,181 high blood pressure patients. The study showed that Rasitrio produced statistically significant blood pressure reductions compared to dual combinations of each of its individual components, including aliskiren/amlodipine 300mg/10mg, aliskiren/HCTZ 300mg/25mg and amlodipine/HCTZ 10mg/25mg. The effect of Rasitrio was observed as early as one week after initiation of therapy and was maintained over the entire 24-hour dose interval1.