Nebivolol – What’s New?

Implications: Implications: Clinical trial results indicate that Nebivolol is a safe and effective antihypertensive agent.As a vasodilating beta-1 selective beta blocker, Nebivolol could compete successfully against long-acting carvedilol and metoprolol.To compete successfully, Nebivolol will have to gain approval for use in heart failure, for which it is approved outside the U.S. Nebivolol presents both marketing and developmental challenges to Forest, and if they can meet these satisfactorily, Nebivolol also offers a good opportunity in a large market.

Analysis:  

The present article indicates that Nebivolol (Forest Laboratories) is an effective agent for treating hypertension. It appears to work well alone or in combination with other antihypertensive agents and in different subsets of patients. The development program as presented represents a fairly standard one for an antihypertensive agent and appears to demonstrate efficacy without safety concerns. Nebivolol is not really a new concept as it is a beta-blocker with some ancillary properties. Like carvedilol (Coreg, GlaxoSmithKline), it also has vasodilating properties, and, like metoprolol (Toprol, Astra-Zeneca) it is a beta-1 selective agent.

Nebivolol is somewhat unique in that it combines the characteristics of carvedilol and metoprolol into a single long-acting agent. It is really not “new”, being marketed extensively outside the U.S. In the U.S. it should be positioned well to compete with carvedilol and metoprolol. Since it is a once daily drug, it will not be at a disadvantage against long-acting carvedilol and metoprolol in this respect. However, because these other agents are also approved for use in heart failure, it behooves Forest to pursue heart failure as a new indication. Nebivolol is approved for use in heart failure outside the U.S. With the eventual addition of a heart failure indication, Nebivolol should be able to compete well against long-acting carvedilol, which is not beta-1-selective, and against metoprolol, which is not a vasodilator. The opportunity is there for Forest to achieve success with Nebivolol, depending on their marketing initiatives and future development of the drug.

[Note: This author is currently or recently has been a consultant to Forest Laboratories, GlaxoSmithKline, and AstraZeneca in the areas of hypertension and/or heart failure relative to all of the products discussed here]