Regulators in the USA have approved Novartis’ Exforge HCT, the only single pill to combine the three most prescribed high blood pressure treatments in their classes in the country.

The US Food and Drug Administration has given the green light to Exforge HCT which combines Exforge (amlodipine and valsartan) and the diuretic hydrochlorothiazide. Novartis says that research suggests up to 85% of patients may need multiple medications and many need three or more to help control their blood pressure.

Following the FDA approval, a patient may be switched to Exforge HCT if blood pressure is not adequately controlled on any two of the following anti-hypertensive classes: calcium channel blockers (eg amlodipine), angiotensin receptor blockers (eg valsartan) and diuretics. Studies show that the full blood pressure lowering effect was achieved two weeks after being on the maximal dose of Exforge HCT.

Novartis quoted David Calhoun of the University of Alabama at Birmingham as saying that with a triple combination option, “appropriate patients may experience a simpler routine of a convenient, once-daily pill to help them control their high blood pressure". Trevor Mundel, head of R&D at at Novartis Pharma, added that the approval “represents a significant milestone toward reducing the burden of unmet need in hypertension".

Exforge and Exforge HCT will be offered at the same price in the USA on a dose equivalent basis, the company said, essentially providing the added diuretic at no additional cost. Exforge HCT is currently under review in the European Union.

Aflunov may useful in swine flu
Meantime Novartis says that new research shows that its pre-pandemic avian influenza vaccine Aflunov, formulated with the firm’s' MF59 adjuvant, could have applications in other H5N1 strains.

Andrin Oswald, chief executive of Novartis Vaccines and Diagnostics, said the data reinforce “the potentially broad applicability of the MF59 adjuvant and the role it can play in pandemic preparedness efforts around the world". He added that the firm will “use these new insights, as well as our strong leadership position in cell-based flu manufacturing”, as part of our efforts to develop a vaccine against swine flu.

Rino Rappuoli, head of research at Novartis Vaccines, added that the findings published about the H5N1 vaccine “suggest a way forward for the present swine flu outbreak". He noted that the firm is working closely with the World Health Organisation, the US Centers for Disease Control and Prevention and other agencies worldwide “on developing a strong and effective response to the outbreak."