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GEN News Highlights : Sep 18, 2009

FDA Clears Novartis’ Combo Pill for Blood Pressure

Treatment offers option for patients requiring multiple blood pressure therapies.

FDA approved Novartis’ blood pressure treatment Valturna®. Clearance in the U.S. represents the first for the drug, which is a single pill combination of Novartis’ angiotensin II receptor blocker, Diovan®, and direct renin inhibitor, Tekturna/Rasilez.

Valturna is indicated for the treatment of high blood pressure in patients not adequately controlled by Diovan or Tekturna/Rasilez monotherapy. It is also sanctioned as initial therapy in patients likely to require multiple blood pressure medications. The drug has also been filed for regulatory review in the EU.

Diovan was Novartis’ top-selling product of the first half of 2009 with sales of $2.9 billion, up 6% on the same period last year. Diovan sales benefited particularly from double-digit growth in Japan, which the company says now accounts for about 20% of the drug’s net sales. In the U.S. a 5% increase in sales of Diovan for the first half of this year was achieved despite generic versions of rival high blood pressure medicines in other classes. 

Exforge is Novartis’ single pill combination of Diovan and the calcium channel blocker amlodipine. In the first half of 2009, Exforge made sales of $304 million, up 96% in local currencies.

Exforge HCT, which adds a diuretic to Diovan-amlopidine combination, received U.S. approval in April. Novartis says the drug is the only high blood pressure therapy to include three medicines in one pill.

Sales of Tekturna/Rasilez were $119 million during this year’s first half, up 117% on the same period during 2008. Novartis says that the drug’s accelerated pace of growth is largely thanks to an increasing body of data affirming its ability to reduce blood pressure for more than 24 hours, its potential benefits for organ protection, and its consistent superiority in clinical trials over the ACE inhibitor ramipril.

Tekturna is also available as a single-pill combination with a diuretic and is marketed as Tekturna HCT in the U.S. Its EU-branded equivalent, Rasilez HCT, was launched in January. A single-pill combination of Tekturna/Rasilez with amlopidine is scheduled for U.S. and EU submissions before the end of this year.