Novartis has received a major boost in the USA after regulators there gave their backing to two of the Swiss major’s combination high blood-pressure drugs which can now be used as first-line treatments.
The US Food and Drug Administration has approved the two single-pill combos – Diovan HCT/Co-Diovan (valsartan and hydrochlorothiazide) and Exforge (amlodipine and valsartan) – as initial therapies in patients likely to need multiple drugs to achieve their blood pressure goals. Novartis says that the approvals reinforce current US guideline recommendations to start appropriate patients on combination therapy as up to 80% of patients may need multiple medications to help them reach blood pressure goals.
Diovan HCT is currently indicated in the USA as a second-line treatment for hypertension, while Exforge got the green light from the FDA last year to treat patients with high blood pressure who had inadequate responses to, or cannot take, other drugs. These latest approvals were based on several clinical trials in approximately 2,000 (Diovan HCT) and 3,500 patients (Exforge) respectively, in which both products demonstrated efficacy and tolerability in patients with mild-to-severe high blood pressure.
Kenneth Jamerson, Professor of Medicine at the University of Michigan, said these approvals “provide flexibility and confidence to physicians to use well-proven and well-accepted therapies as first-line treatment”. He added that “patients will also benefit, as they may be able to get their blood pressure effectively and quickly under control with a single pill”.
The FDA’s backing will help push sales of the two treatments which are already strong. In the second quarter, the Diovan (valsartan) range of products put in a stellar performance, with revenues up 22% to $1.50 billion, while Exforge brought in $101 million.
