Novartis to revise Rasilez labelling on CHMP guidance

Novartis has announced that it will be making amendments to the product information details for its high blood pressure therapy Rasilez.

The pharmaceutical company will follow the advice of the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) to update the drug's labelling to include contraindications against combined use with a number of products.

According to the CHMP, Rasilez and other products containing aliskiren should not be used alongside ACE inhibitors or ARBs in patients with diabetes and/or moderate to severe renal impairment, due to safety concerns.

However, the committee endorsed the drug's overall risk/benefit profile and concluded that it remains an effective therapy for essential hypertension.

David Epstein, division head of Novartis Pharmaceuticals, said: "We are working closely with the CHMP, EMA and other health authorities worldwide to continue to provide Rasilez and combination products containing aliskiren to the most appropriate patient population who would benefit."

Last month, the company received backing from the CHMP to make a label update to its drug Glivec available to post-surgical gastrointestinal stromal tumour patients.