High blood pressure and its consequences affect one in four adults, more than a billion people worldwide, and kill more than 7 million people every year. Type 2 diabetes causes 3 million deaths annually. Both diseases remain under-diagnosed and poorly treated, but Novartis is poised to expand its broad cardiovascular and metabolism portfolio by offering patients and physicians breakthrough innovations with the potential to transform treatment.
US regulatory approval of Exforge in December culminated a year packed with submissions and decisions for Novartis, setting the stage for a series of major launches over the next two years.
Exforge is the first treatment for high blood pressure to combine the two most commonly prescribed antihypertensive medicines in their classes: Diovan and the calcium channel blocker amlodipine besylate.
Tentative approval by the US Food and Drug Administration (FDA) will permit the launch of Exforge in September 2007, after the expiration of market exclusivity for amlodipine besylate.
In an extensive clinical program involving over 5,000 patients, Exforge helped up to 9 out of 10 patients reach their treatment goal (diastolic blood pressure under 90mmHg or more than a 10mmHg reduction in diastolic pressure from baseline). That high proportion of treatment success stands in sharp contrast to the estimated 7 out of 10 people with high blood pressure today who either remain undiagnosed or fail to reach their blood pressure targets.
ÔÇ£Exforge offers a potential solution to many people with high blood pressure who currently need two or more medicines to control their illness,ÔÇØ says James Shannon, MD, Head of Pharmaceutical Development at Novartis.
Meanwhile, two additional breakthrough medicines from Novartis are poised to fortify the dynamic portfolio of the Cardiovascular and Metabolism Franchise. Galvus (vildagliptin) and Tekturna (aliskiren) completed clinical testing last year and are now under regulatory review in both the US and Europe for treatment of type 2 diabetes and hypertension, respectively.