EC APPROVES NEW DRUGS FOR BLOOD PRESSURE, DIABETES

The European Commission (EC) this week approved two new combination drugs. Novartis announced yesterday that it was granted approval for Exforge, a single-pill treatment for patients with high blood pressure. Exforge combines in one tablet the two most commonly prescribed branded hypertension medicines — Diovan (valsartan) and Norvasc (amlodipine besylate). Exforge is indicated for the treatment of hypertension in patients whose blood pressure is not adequately controlled by amlodipine or valsartan alone.

It will be introduced first in Germany followed by launches in most other European Union countries throughout the year, pending expiration of the patent protection for Norvasc. In the U.S. the drug has been granted tentative approval.

In addition, Takeda Pharmaceutical announced that it was granted European marketing authorization for Tandemact (pioglitazone/glimepiride), a fixed combination tablet of Actos (pioglitazone HCl) and glimepiride HCl to treat Type 2 diabetes.

Actos is a member of the thiazolidinedione class of insulin-sensitizing agents, and it directly targets insulin resistance. Glimepiride acts primarily by increasing the amount of insulin produced by the pancreas. These medications work in combination to help patients with Type 2 diabetes manage their blood glucose levels, according to the company. The drug was approved in the U.S. in August 2006.