Aliskiren regulatory update

EMA's CHMP recommended updating the label for Novartis' hypertension drug Rasilez/Tekturna aliskiren and other aliskiren-containing products to include a contraindication for patients with diabetes or moderate-to-severe renal impairment who take angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARB). CHMP also recommended the inclusion of a warning that the combination of aliskiren and an ACE inhibitor or ARB is not recommended in all other patients because adverse outcomes cannot be excluded.

CHMP began the safety review last December after data released from the Phase III ALTITUDE trial showed that Rasilez plus standard of care led to an increased incidence of non-fatal stroke, renal complications, hyperkalemia and hypotension vs. standard of care alone (see BioCentury, Jan. 2). ...