Novartis has received a very welcome boost with the news that the firm’s blood pressure drug Tekturna has been given the green light by US regulators.
The US Food and Drug Administration has approved Tekturna (aliskiren), also known as Rasilez, for the treatment of high blood pressure as monotherapy or in combination with other such medications and it will be available in 150mg and 300mg. Novartis noted that the treatment, which is partnered with Swiss biotech group Speedel, is the first in a new class of drugs called direct renin inhibitors “and the first new type of medicine in more than a decade for treating high blood pressure” which affects nearly one billion people worldwide and remains uncontrolled in nearly 70% of patients.
James Shannon, head of development at Novartis Pharma noted that many patients require two or more medicines to control their blood pressure and “as a new treatment approach, Tekturna has the potential to help these patients manage their disease." The company is still waiting to hear from European Medicines Agency after Tekturna was filed for review in September 2006 and analysts have estimated potential global sales of $1.5 billion for the drug by 2012.
The FDA approval comes some three months after Novartis had revealed that the agency’s review of the drug had been delayed while additional new data was being submitted and comes at a time when the Swiss drugs major has been having a tough time getting its medicines passed. The biggest recent blow was the FDA’s request for additional information, and a new clinical study, on the firm's new diabetes drug Galvus (vildagliptin).
The Tekturna approval saw Novartis shares rise in early trading on Thursday, and Speedel’s stock is soaring. The news should also please the drugs major’s shareholders who are gathering for Novartis’ annual general meeting in Basle later today and some observers are expecting a stormy session. Investors have been less than impressed with its recent share performance and it is thought that chief executive Daniel Vasella can expect a rough ride.