A Setback for a Schering-Plough Drug
By REUTERS
Published: August 2, 2008
The Schering-Plough Corporation, the pharmaceutical company, said Friday that regulators had rejected Bridion, its drug to reverse the effects of anesthesia that had been heralded as a breakthrough product by analysts and was unanimously recommended by a federal advisory panel.
The Food and Drug Administration issued a “not-approvable” letter for the injectable medicine, also known as sugammadex. The agency cited concerns primarily related to hypersensitivity and allergic reactions to the product but raised no concerns about its effectiveness, the company said.
Schering-Plough did not describe the allergic reactions. In other drugs used to reverse anesthesia, they can range from decreases in blood pressure to increases in heart rate.
It was considered a significant product from Schering-Plough’s $14.5 billion purchase last November of Organon Biosciences. Some analysts estimated it could generate annual sales of up to $1 billion if approved in the United States.
“We are surprised and disappointed with this action, especially given that sugammadex received a unanimous recommendation for approval by the F.D.A. Advisory Committee on Anesthetics and Life Support in March of this year,” Thomas Koestler, Schering-Plough’s research chief, said in a statement.
The company said it would continue to press for approval of the drug and was trying to address safety issues with the F.D.A.
Bridion was approved by the European Commission on Tuesday, after a favorable recommendation last month by its own advisory panel.
Schering-Plough has been counting on Bridion and other products from the Organon deal to help ensure earnings growth. The earnings outlook for Schering-Plough has worsened this year, after negative findings for its Vytorin cholesterol fighter in two clinical trials that have hurt sales of the blockbuster product, which is sold in partnership with Merck and Company .
Bridion was approved in Europe for reversal of neuromuscular block, or temporary paralysis, induced by the widely used muscle relaxants, rocuronium and vecuronium.
It was shown in trials to reverse effects of neuromuscular blockade within minutes — 9 to 12 times faster than the standard reversal agent, neostigmine.
Neuromuscular blockade is used by anesthesiologists to cause paralysis during surgical procedures, particularly of the abdomen, chest and brain. But patients require breathing tubes until the drugs wear off or are reversed.
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