Novartis has filed for approval of a new combination product, Exforge, that could provide a more effective treatment for the 70% of hypertension patients who do not meet their blood pressure targets using monotherapy.
Exforge (amlodipine and valsartan), is a fixed-dose combination of the two most-prescribed anti-hypertensives in the marketplace, according to Novartis.
The company is seeking approval for Exforge for use in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy, and as replacement therapy for patients taking amlodipine and valsartan as a free combination.
"About two-thirds of patients currently take two or more drugs to control their blood pressure," said James Shannon, head of development at Novartis Pharma. "This can be very problematic since the burden of having to take multiple pills is one of the main contributors to poor compliance."
Exforge is one of two high blood pressure treatments to be filed by Novartis in the first half of this year. The other is Rasilez (aliskiren), a first-in-class renin inhibitor licensed from Speedel Laboratories.
Novartis said recently it has high hopes for the latter drug, which has a benign side effect profile that rivals the firm's $3.7 billion Diovan (valsartan) product, but seems to be better at lowering blood pressure and offers 24-hour hypertension control.
Analysts estimate that Rasilez has potential to be a blockbuster product with sales in excess of $1 billion, while Exforge could be a useful addition the firm’s hypertension franchise, bringing in up to $500 million at peak.