Novartis' Exforge NDA accepted for review by FDA as high-blood pressure treatment option

Swiss drug major Novartis says that a New Drug Application relating to the drug Exforge (amlodipine and valsartan) was accepted for review by the US Food and Drug Administration as a treatment for patients with high blood pressure. The announcement follows the filing of a similar submission with the European Medicines Agency that the firm completed earlier in the year (Marketletter March 13).

The company estimates that more than 65 million US citizens, or one in three adults, suffer from high blood pressure, with approximately 70% of cases not well controlled. In addition, it says that research has shown the researchers say that nearly half of those diagnosed with hypertension have not achieved their target blood pressure goal after treatment. Globally, the condition is thought to the world's most common cause of death and is estimated to affect one billion adults leading to a higher incidence of heart attack, stroke, heart and kidney failure.

James Shannon, head of development at Novartis Pharma, said that the company, having identified a relatively poorly-served area of medical need, is aiming to create an agent that can help patients reach and maintain their target blood pressure levels, and added that the combined formulation would improve treatment adherence over the long term.