Switzerland’s Novartis has filed for US approval of a single-tablet combination of its antihypertensive Tekturna, which only got the green light on the other side of the pond a couple of months ago, and a widely-used diuretic.
The company said that new clinical data involving 1,625 patients, which is being presented later today at the American Society of Hypertension meeting in Chicago, showed that Tekturna (aliskiren) produced significant blood pressure lowering effects over a one-year period, both alone and in combination with the diuretic hydrochlorothiazide. Tekturna plus HCT was generally well tolerated, with the most common side effects in this study
being bronchitis (6.1%), nasopharyngitis (5.1%) and headache (3.5%).
The submission of Tekturna HCT to the US Food and Drug Administration is based on data from seven clinical trials involving more than 6,200 patients, including the data presented at ASH meeting, for four different dosage
combinations – 150/12.5mg, 150/25mg, 300/12.5mg and 300/25mg. Tekturna, which was developed in collaboration with fellow Swiss firm Speedel, is the first approved direct renin inhibitor and was given the go-ahead in the USA in March. Novartis said it expects a decision on European Union approval, where the drug will be known as Rasilez, by the end of the year.
Teva’s bid to sell generic Lotrel halted
Novartis also noted that a US federal district court had issued a temporary restraining order preventing Teva Pharmaceuticals Industries from launching a generic version of the hypertension treatment Lotrel (almodipine/benazepril). The decision came hours after the Israeli-based company had announced that its copycat version of the drug had received FDA approval.
Teva had been awarded 180 days’ exclusivity for the products but a hearing has been set for later today to review the temporary order and proceedings in ongoing patent litigation between the two companies. Novartis’ US patent on Lotrel does not expire until 2017 and the company filed an infringement lawsuit against Teva in September 2004.