Mylan gets US FDA nod for hypertension drug Bystolic

The US Food and Drug Administration has approved the novel beta blocker hypertension drug Bystolic (nebivolol) manufactured by Mylan Inc.

Forest Laboratories, Inc. will market the prescription drug to the US under the name Bystolic and will pay Mylan undisclosed royalty payments as part of their collaboration agreement. . Forest licensed US and Canadian rights to Bystolic from Mylan Inc. in January 2006. Forest will market Bystolic in the US. The company expects Bystolic would be available to physicians, patients, and pharmacies in January 2008.

Bystolic is a once daily medication that can be used alone or in combination with other hypertension treatments. Hypertension affects approximately 72 million adults in the US and 65 per cent of patients diagnosed with hypertension have not reduced their blood pressure to an acceptable range, underscoring the need for additional therapeutic options.

Beta blockers are one of the most widely used classes of drugs in the United States. In an extensive clinical trial program involving more than 2,000 patients, Bystolic demonstrated significant reductions in sitting diastolic and systolic blood pressure in a general hypertensive population, which included 26 per cent Black, 54 per cent male, 19 per cent elderly and 8 per cent diabetic patients. The studies also found that Bystolic was well tolerated, with a low incidence of traditional beta blocker side effects. Like other beta blockers, Bystolic decreases heart rate and myocardial contractility, and suppresses renin activity. Bystolic is a selective beta 1 blocker at doses less than or equal to 10 mg per day and has the added pharmacological properties of producing vasodilation and reducing total peripheral resistance.

"Bystolic is the newest beta blocker approved for the treatment of hypertension in the US and should prove useful due to its efficacy in a broad range of patients and its favourable side effect profile," said Michael Weber, MD, Professor of Medicine at SUNY Downstate College of Medicine. "These features will be attractive to both physicians and patients."

Howard Solomon, chairman and chief executive, Forest, commented: "We, along with our partner Mylan, are pleased to have received final Food and Drug Administration marketing approval for Bystolic. Bystolic represents an important advance for patients with hypertension and the physicians who treat them and will be an important new product for our Company."

Bystolic is already approved and successfully marketed for the treatment of hypertension in more than 50 countries outside of North America. Mylan licensed the US and Canadian exclusive rights to nebivolol from Janssen Pharmaceutica N.V., Belgium in 2001.

Patients being treated with Bystolic should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported following the abrupt cessation of therapy with beta blockers. When discontinuation is planned, the dosage should be reduced gradually over a one to two week period and the patient carefully monitored.

Bystolic is contraindicated in severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), severe hepatic impairment (Child-Pugh >B), and in patients who are hypersensitive to any component of this product.Like other beta blockers, Bystolic should be used with caution in patients with peripheral vascular disease, thyrotoxicosis, severe renal impairment, and any degree of hepatic impairment or in patients undergoing major surgery. The most common adverse events with Bystolic were headache, fatigue and dizziness.