Merck hit with delay on FDA review of top drug prospect

Merck ($MRK) will have to wait longer than expected for the FDA to decide the fate of sugammadex. The agency has delayed by three months its review of the closely watched therapy for reversing anesthesia, making Merck wait until the second half of 2013 for a regulatory decision.

The U.S. drug giant had hoped for an FDA approval for sugammadex by midyear, as the company seeks ways to capitalize on an expensive pipeline that has been slow to deliver new drugs. And news of the delay on the U.S. regulatory review of the top prospect comes about a week after Merck said it would bring in ex-Amgen ($AMGN) R&D chief Roger Perlmutter to replace Peter Kim, who has reigned over an $8 billion annual research effort that has failed to impress.

Sugammadex has a history of regulatory delays. Five years ago U.S. regulators rejected sugammadex, which Merck took on through its megamerger with Schering-Plough in 2009, over concerns about allergic reactions to patients. Merck and before it Schering have touted the compound as an important advance in anesthesia, a field that hasn't seen much innovation in years. And Reuters reports that industry watchers and physicians have supported that case.

As Dow Jones noted, Merck already sells sugammadex outside of the U.S. under the brand name Bridion, and global sales of the product in 2012 were $261 million. Merck is angling to significantly grow its sugammadex business with the hoped-for approval in the U.S.

Blockbusters have been slow to exit Merck's pipeline. Kim can reflect on the past several years and highlight the FDA approval of the company's top-selling DPP-4 inhibitor Januvia for diabetes. Yet that green light came in 2006, and regulators are harping on the risks of pancreatic cancer in patients on Januvia and other popular diabetes drugs.

Perlmutter, who had worked for Merck before joining Amgen ($AMGN), has his work cut out for him.

- here's the Dow Jones article
- and the update from Reuters

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