Despite a recommendation by an FDA advisory panel and a positive nod by European regulators, Schering-Plough's novel anesthesia injection Bridion was deemed "not approvable" by FDA, a move that could stall the product's U.S. launch by years.

Kenilworth, N.J.-based Schering Plough said Aug. 1 it was "surprised and disappointed" by FDA's negative decision on Bridion (sugammadex), a selective agent used to reverse muscle relaxant effects after anesthesia.

The firm said it remains fully committed to Bridion and is working to resolve the agency's concerns, which are related mainly to reports of hypersensitivity/allergic reactions.

Additional studies could be required to address FDA's concerns, which led Credit Suisse analysts to the expected U.S. launch date for the drug from the fourth quarter to the first quarter 2011.

FDA's Anesthetic and Life Support Drugs Advisory Committee voted unanimously in favor of approving Bridion for the routine reversal of shallow and profound neuromuscular blockade, as well as "immediate" NMB reversal (¹ Also see "Schering-Plough’s Bridion Makes Positive Impression On Advisory Panel" - Pink Sheet, 11 March, 2008.). However, the panel did not actually make a formal recommendation for approval because some data were submitted late in the review process.

FDA pushed back Bridion's user fee date by three months to July, giving the agency time to assess a clinical report on a hypersensitivity study (² Also see "FDA Postpones PDUFA Date For Schering-Plough’s Bridion To Third Quarter" - Pink Sheet, 19 March, 2008.).

In addition to the positive panel review in the U.S., Bridion has been well-received in Europe, where it received a positive opinion for use in adults and children with the relaxants Exmeron (rocuronium) and Norcuron (vecuronium) (³ Also see "Europe Likes Schering’s Bridion, But Not Takeda’s Rozerem" - Pink Sheet, 3 June, 2008.).

FDA decisions are "increasingly unpredictable"

The U.S. rejection comes as a bit of a surprise, given the advisory committee recommendation, but as Sanford C. Bernstein & Co. analyst Tim Anderson wrote in an Aug. 1 research note, FDA "has become increasingly unpredictable."

"In a controlled setting like the operating room, hypersensitivity is something that would seem to be controllable," he added.

Credit Suisse's Catherine Arnold also noted that hypersensitivity/allergic reactions were not mentioned as a significant concern by the FDA advisory committee, nor were they seen as an issue in pivotal trials.

"We believe that Bridion's benefit/risk profile will ultimately garner approval [for the drug] in the U.S.," she wrote. "Today's news is an incremental negative but is manageable."

- Emily Hayes (e.hayes@elsevier.com)

Schering Plough’s Bridion Faces FDA Setback

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