US regulators have approved Novartis’ Tekturna HCT, a single-tablet combination of two high blood pressure medicines, as initial therapy for patients who are likely to need multiple drugs.

The drug combines Tekturna (aliskiren; sold as Rasilez outside the USA), the only approved direct renin inhibitor, and the diuretic hydrochlorothiazide in a single pill. It was approved across the Atlantic for second-line treatment of high blood pressure at the beginning of 2008 and this latest expansion by the US Food and Drug Administration will boost sales of the Tekturna franchise which reached $67 million in the second quarter.

The Basel-based major quoted Alan Gradman, professor of medicine at Temple University as saying that “up to 85% of patients will need more than one medication to reach their blood pressure goals”. This approval “gives doctors the opportunity to aggressively treat their patients with a single-pill combination [which] results in more significant blood pressure reductions, compared to taking either drug alone”.

Novartis also noted that current US treatment guidelines support the first-line use of combination therapy in appropriate patients and “multiple medications may help patients achieve blood pressure goals in a more timely fashion”. Speaking last week on a conference call for the firm’s second-quarter results, Novartis pharma chief Joe Jimenez said that Tekturna may generate sales of up to $300 million this year.

Alnylam deal extended
Meantime, Alnylam Pharmaceuticals has revealed that Novartis has elected to extend the companies’ RNAi therapeutics collaboration for a fifth and final planned year, through October 2010. The alliance, initiated in October 2005, is focused on the discovery, development, and commercialisation of RNAi therapeutics toward a defined number of Novartis-selected disease gene targets.