Novartis sales and marketing update

Novartis will withdraw Valturna aliskiren/valsartan from the U.S. market, effective July 20. Valturna is indicated to treat hypertension in patients not adequately controlled with monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. Additionally, Novartis will also withdraw an MAA for the product in Switzerland, where the product was not marketed.

The moves follow FDA's requests for label changes to include a contraindication against the use of aliskiren-based products with angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARB) in patients with diabetes and in patients with moderate-to-severe renal impairment. The label change was based on FDA's review of preliminary data from the Phase III ALTITUDE trial, which showed aliskiren plus standard of care (SOC) - an ACE inhibitor or ARB - led to an increased incidence of non-fatal stroke, renal complications, hyperkalemia and hypotension after 18-24 months vs. placebo plus SOC (see BioCentury, Jan. 2). ...