Novartis wins FDA approval for blood pressure combination therapy

Novartis has reported that the FDA has approved Exforge HCT, claimed to be the only blood pressure treatment to combine three medications in a single pill. This FDA approval was based on a clinical trial of Exforge HCT of over 2,000 patients.

According to Novartis, Exforge HCT combines the number one prescribed calcium channel blocker, angiotensin receptor blocker, and diuretic in one pill, and is an important new option for patients who have tried taking dual combinations of these classes of blood pressure medications without success.

It is reported that Exforge HCT contains three effective medicines that work in three different ways. A patient may be switched to the single pill combination Exforge HCT if blood pressure is not adequately controlled on any two of the following anti-hypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics. The full blood pressure lowering effect was achieved two weeks after being on the maximal dose of Exforge HCT, the company said.

Exforge and Exforge HCT will be offered at the same price in the US on a dose-equivalent basis, essentially providing the added diuretic in Exforge HCT at no additional cost. Since Exforge HCT combines three medications in a single pill, patients may benefit from reduced insurance co-payments, the company added.

Trevor Mundel, global head of development at Novartis Pharma, said: This approval of Exforge HCT as the only single blood pressure pill combining the efficacy of three of the most-prescribed treatments in their classes represents a significant milestone toward reducing the burden of unmet need in hypertension.

Novartis remains confident in the important role of single pill combination medications to help appropriate patients achieve their blood pressure targets, while providing physicians with a range of powerful yet flexible combinations of doses to effectively manage high blood pressure in different patients.