Novartis blood pressure drug Rasilez – sold in the U.S. under the brand name Tekturna – will get new safety warnings in Europe at regulators’ request, after a clinical trial was halted because subject patients experienced a high rate of strokes and kidney problems.
According to a report from Bloomberg News, Novartis, the maker of Rasilez/Tekturna announced that it would comply with a recommendation made by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Swiss drugmaker will revise the drug’s European label to say that Rasilez should not be used in patients with diabetes or kidney problems who are also using ACE inhibitors or angiotensin receptor blockers. Like Rasilez, ACE inhibitors and ARBs are used to treat high blood pressure.
“This decision comes after extensive interactions between Novartis and the CHMP. Patient safety continues to be the highest priority for Novartis, and 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,” David Epstein, Division Head of Novartis Pharmaceuticals, said in a statement.
Rasilez/Tekturna was brought to market in 2007, and Novartis had high hopes that the drug would become a blockbuster. It is approved as a treatment for hypertension (high blood pressure) either as monotherapy or in combination with other medications.
However, the EMA launched a review of the drug after Novartis announced in December that it had halted a study known as ALTITUDE after an independent review committee noted higher adverse events in patients receiving Rasilz/Tekturna in addition to standard of care in the trial. There was also an increased incidence after 18-24 months of serious side effects in the high risk population, including non-fatal stroke, kidney complications, hyperkalemia (high potassium), and hypotension (low blood pressure).
The ALTITUDE trial was a multinational study involving 8,606 patients from 36 countries evaluating the potential benefits of Rasilez/Tekturna to reduce the risk of cardiovascular and renal events in people with type 2 diabetes and kidney impairment.
As a precautionary measure, Novartis stopped promotion of the drug and combination products containing aliskiren in combination with an ACE inhibitor or ARB in December. According to The Wall Street Journal, Novartis also wrote to physicians world-wide recommending that patients with Type 2 diabetes shouldn’t be treated with aliskiren, or combination products containing aliskiren, if they are also receiving an ACE inhibitor or ARB. Novartis said that recommendation remains in effect in countries outside Europe, including the U.S.
“In addition, the agency recommended the inclusion of a warning that the combination of aliskiren and ACE inhibitor or ARB is not recommended in all other patients because adverse outcomes cannot be excluded,” the EMA’s Committee for Medicinal Products for Human Use said.
Since the trial was stopped in December, the company has downgraded its long-term expectations for the drug and taken a $900 million charge related to that lower forecast, Bloomberg notes. Novartis now says 2012 sales will be less than half of the $557 million posted last year. The company had been hoping the products would help fill the gap left when its older blood-pressure remedy Diovan goes off patent later this year.
The company is also working with the FDA on guidelines for use of the drug.