Novartis says that regulators in Japan have given the green light to its novel blood pressure pill Rasilez.

The country's Ministry of Health, Labour and Welfare has approved Rasilez (aliskiren) , its first-in-class direct renin inhibitor sold in the USA as Tekturna, to treat high blood pressure alone or in combination with other antihypertensives. In Japan, 40 million people, nearly a third of the population, are affected by the condition, and Toshiro Fujita of the University of Tokyo noted that “nearly 70% of patients are not reaching their blood pressure goal, demonstrating a strong need for therapies with a new mechanism of action”.

The professor said it is expected that Rasilez’s “unique mechanism of action will provide significant blood pressure reductions that last for 24 hours”. Novartis added that the potential long-term benefits of Rasilez are currently being investigated further in ASPIRE HIGHER, the largest ongoing cardio-renal outcomes programme worldwide, involving more than 35,000 patients in 14 trials.

Rasilez is available in over 70 countries and the single pill combination Tekturna HCT (aliskiren/hydrochlorothiazide) was approved in the USA in January 2008. The latter was approved in Europe of the beginning of this year.

Nail fungus treatment terminated
Meantime, Novartis and the US firm NexMed have terminated development of NM100060, a nail fungus product.

The decision was taken after data from two Phase III studies of NM100060, a topically-applied treatment for onychomycosis, were deemed insufficient to support filing for marketing approval. Novartis signed a deal for the treatment in September 2005 and had assumed “all clinical development, regulatory, manufacturing and commercialisation responsibilities for the drug”, Nexmed said.

The New Jersey-based company’s chief executive Vivian Liu, remained upbeat and said “there were lessons learned from the studies which warrant further development of this product”. He added that NexMed has already “received inquiries from companies with a focus in dermatology who are interested in commencing discussions” about licensing NM100060 but his confidence did not stop NexMed stock from suffering a collapse.