The FDA approved Novartis’ Exforge, a hypertension drug combining two currently marketed cardiovascular medicines.
Novartis called the approval “tentative,” as it won’t launch Exforge until late September 2007 pending the expiration of market exclusivity and patent protection for Pfizer’s Norvasc (amlodipine besylate). The new pill brings together Norvasc, a calcium channel blocker, with Novartis’ Diovan (valsartan), an angiotensin II antagonist.
Analysts say the most obvious market for Exforge are the over $4.5 billion of global sales Pfizer makes with Norvasc, but the pill also may help to prolong the life cycle for Diovan.
Both Norvasc and Diovan are the top-selling therapies in their respective categories. Norvasc had US sales of $2.6 billion in 2005, while Diovan racked up 2005 sales of $1.04 billion, according to IMS Health.
In November, Exforge received 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 said, adding it expects approval from the European Commission and launch in the EU during the first half of 2007.
Novartis has another hypertension drug under review, the renin inhibitor Tekturna (aliskiren). A spokesman said the firm expects a US regulatory decision in the first half of 2007.