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news.Novartis has received US regulatory approval for its hypertension drug Exforge, which combines Novartis' Diovan and Pfizer's Norvasc in one tablet.
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The FDA issued this tentative approval because Exforge has met all the required standards for safety, efficacy and manufacturing quality. Exforge is expected to be available to patients in the US in late September 2007, pending the expiration of market exclusivity and patent protection for Norvasc.
Novartis said that in its clinical trials involving 5000 patients, once-daily Exforge helped up to nine out of 10 patients reach their treatment goal (diastolic blood pressure under 90 mmHg or more than a 10 mmHg reduction in diastolic blood pressure from baseline).
James Shannon, global head of development at Novartis, said: “Exforge promises to be an attractive therapy option because it brings together two of the most powerful mechanisms of action in a single pill.”
In November, Exforge was granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), the regulatory agency that reviews European Union submissions for new medicines. Novartis expects to receive approval from the European Commission and to make Exforge available in the EU during the first half of 2007.