The European Commission approved Rasilez alone or in combination with other high blood pressure therapies, based on data from more than 7,800 patients in 44 clinical studies which was submitted by Novartis in September 2006. The approval applies to all 27 EU member states plus Iceland and Norway.
Razilez was approved by the FDA in the US in March 2007 under the trade name Tekturna to treat hypertension both as monotherapy and in combination with other anti-hypertensives. In July 2007 the drug was also approved in Switzerland.
Speedel developed Razilez through Phase I and II clinical trials before Novartis exercised its license-back option in 2002.
Dr Alice Huxley, Speedel’s CEO, said: “There is a clear unmet medical need in this therapeutic area with more than 40% of treated patients not achieving control levels for their high blood pressure – even when using existing therapies. This approval is a welcome step bringing SPP100 (Rasilez) to patients in Europe as the first novel therapy for treating high blood pressure since 1995.”