Novartis Gets Sooner Than Expected FDA Approval for Hypertension Drug

Swiss drug giant Novartis AG said this morning U.S. regulators have approved its Tekturna hypertension drug, the first new treatment for high blood pressure in over ten years. The FDA had previously said it would need another three months to review the drug, which had prompted concern the FDA would either not allow the drug or limit its use. Novartis said Tekturna now has approval for use on its own or with other hypertension drugs, and should be available to U.S. consumers this month. The U.S. is the first country in the world to approve Tekturna tablets, the first in a new class of drugs called direct 'renin inhibitors' that target renin, an enzyme responsible for triggering a process that can contribute to high blood pressure. The drug complements Novartis's heart-treatment line, which includes Diovan and Lotrel. It could help shore up future sales when these medicines lose their patent protection starting in 2012. Bloomberg says the product is expected to generate sales in excess of $1 billion/year. Novartis shares are up 2.6% ($1.42) to $56.05 in pre-market trading as of 8:08 EST.

Sources: Press Release, MarketWatch, Bloomberg
Commentary: Pfizer Successfully Defends Hypertension Drug Again, This Time Against Mylan • Big Pharma's Big Decision: Diversify Or Focus? • Novartis: Strong Growth and Reasonable Valuation
Stocks/ETFs to watch: Novartis AG (NVS). Competitors: Pfizer Inc. (PFE), Merck & Co. Inc. (MRK), Johnson & Johnson (JNJ), Mylan Laboratories Inc. (MYL), GlaxoSmithKline plc (GSK), sanofi-aventis (SNY). ETFs: iShares NASDAQ Biotechnology Index ETF (IBB), HOLDRS Biotech (BBH), PowerShares Dynamic Biotech & Genome (PBE)

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