Novartis announces Tekturna HCT FDA approval

Novartis has received approval from the Food and Drug Administration (FDA) for its Tekturna HCT (aliskiren and hydrochlorothiazide) tablets as an initial treatment for people deemed likely to require multiple therapies to reach their blood pressure goals.

In a statement, the organisation explained that the approval was based on data gleaned from a clinical trial involving more than 2,700 participants.

The study showed that the drug, which is a single-pill combination of Tekturna (aliskiren) and the diuretic hydrochlorothiazide (HCTZ), was more effective at reducing blood pressure than when either treatment was used on its own.

Dr Trevor Mundel, global head of development at Novartis, said that the firm, which reported an increase in net sales of 12 per cent in the first half of 2009, is “very pleased” with the FDA’s decision.

“Novartis is committed to supporting the research and development of effective treatments for high blood pressure that will help patients reach their blood pressure treatment goals,” he added.