Novartis is celebrating the news that the firm’s new blood pressure drug Rasilez has been approved for use in the European Union, five months after regulators in the USA gave the go-ahead for the drug, where it is sold as Tekturna.
The European Commission has approved Rasilez (aliskiren) for the treatment of high blood pressure alone or in combination with other such medicines, based on data from more than 7,800 patients in 44 clinical trials. The approval applies to all 27 EU member states plus Iceland and Norway and Novartis noted that “nearly half of all adults in Europe's largest countries, such as Germany, Italy and the UK, suffer from this potentially life-threatening condition”.
Rasilez, which was co-developed with fellow Swiss firm Speedel, is the first medicine to directly target high blood pressure at its source, the enzyme renin, said Roland Schmieder, professor of medicine at the University of Erlangen-Nuremberg, Germany. He added that “our biggest challenge is getting blood pressure under control in the first place and then keeping it there. Because Rasilez works well alone or with other medicines, it shows good promise in helping patients, even those who haven't yet achieved control with other medicines."
Novartis noted that when used alone, Rasilez demonstrates greater blood pressure lowering than other commonly-used treatments like ACE inhibitors] and the diuretic hydrochlorothiazide. It consistently lowers blood pressure for 24 hours and beyond, which is particularly important given that many medicines fail to work around the clock, especially during the early morning hours when blood pressure often surges.
"Direct renin inhibition is the only major innovation in treating high blood pressure for more than a decade," said James Shannon, head of development at Novartis Pharma, and the company noted that the drug’s long-term potential in high blood pressure patients with heart failure or kidney failure is currently being studied, with data expected to be released later this year.
Teva gets FDA approval for generic Famvir
Less pleasing for Novartis was the news that Teva Pharmaceutical Industries has won approval from the US Food and Drug Administration to market a generic version of the genital herpes drug Famvir (famciclovir), which had sales of around $200 million in the USA for the twelve months ended June 30.
The Israeli drugmaker noted that as the first company to file an Abbreviated New Drug Application for the product, it has been awarded a 180-day period of marketing exclusivity. However, a patent infringement suit was brought by Novartis in April 2005 and its bid to get an injunction on Teva’s copycat version will be heard in a New Jersey court on September 5. Until a decision in that case is made, both parties have agreed not to launch a generic famciclovir product.