Novartis makes Tekturna label change, updates on Gilenya and stops alisporivir trial

In a day of mixed news for the Swiss drug major, Novartis (NOVN: VX) said yesterday that it has updated its hypertension drug Tekturna/Rasilez (aliskiren) label in consultation with the US Food and Drug Administration to include warning against the combined use of aliskiren-based products with ACE inhibitors or angiotensin receptor blockers (ARBs) in patients with diabetes.

In addition, the FDA has requested the company to include contradictions of aliskiren-based products with ACE inhibitor and ARBs in patients with moderate renal impairment (eGFR < 60ml/min). The update follows the FDA’s review of preliminary finding from the ALTITUDE study.

Furthermore, and in consultation with the FDA, Novartis has decided to voluntarily cease marketing in the US of Valturna, a single pill combination of aliskiren and the ARB valsartan. Valturna sales in the US represented less than 10% of aliskiren sales in 2011. Global turnover of Tekturna amounted to $557 million last year.