Novartis announced this morning that US regulators have given the seal of approval to its new blood pressure agent Tekturna HCT, a single-tablet combination of two high blood pressure medicines.
The product combines Tekturna (aliskiren; sold as Rasilez outside the USA), which the group says is the first new type of high blood pressure medicine in more than a decade, and the diuretic hydrochlorothiazide in a single pill, providing a potential new option for the one in four adults who suffer from high blood around the globe.
Clinical trials have shown Tekturna to be effective in controlling blood-pressure for periods of at least 24 hours, an important benefit as many rival therapies on the market “fail to work around the clock, especially during the early morning hours when blood pressure often surges”, the company explained, while HCT is one of the most popular therapies on the market.
The green light marks the first regulatory approval of a combo involving Tekturna to be allowed onto the US market, and Novartis is hopeful that it will help a significant number of patients with uncontrolled blood pressure reach their target levels.
“Current guidelines call for aggressive treatment of high blood pressure and many patients are still not controlled,” explained Alan Gradman, Division of Cardiovascular Diseases at the Western Pennsylvania Hospital in Pittsburgh, USA. “Tekturna HCT offers patients an effective new treatment option with significant blood pressure reductions and improved convenience, by combining the complementary mechanisms of action of the first direct renin inhibitor and a diuretic in one tablet.”
“Most patients need at least two medicines to control their high blood pressure,” added James Shannon, MD, Chief Medical Officer at Novartis Pharma AG. “The rationale for combining a diuretic, which raises plasma renin activity, with Tekturna, which counters this increase, is compelling and unique, and Novartis is very proud to introduce this innovative combination”, he said.
Exelon agreement
Meanwhile, there was further good news for Novartis this morning, after the group settled an ongoing dispute with Indian generic drugmaker Dr Reddy’s Laboratories over its Alzheimer’s drug Exelon (rivastigmine).
In a note to the Bombay Stock Exchange, Dr Reddy’s said it has agreed to delay the roll out of a copycat version of the drug “until sometime before the expiry of the Orange Book patents”, but that specific terms remain confidential.
In October 2007, the Indian firm received the final approval from the FDA on its application to sell generic rivastigmine capsules.
