EU OKs "breakthrough" new anesthesia drug
NEW YORK (Reuters) - European regulators have approved a breakthrough new medicine to help patients emerge far more quickly from anesthesia than existing treatments,
Schering-Plough Corp , the maker of the medicine, said on Tuesday.
The U.S. drugmaker has said the injectable drug, called Bridion, is one of the biggest advances in anesthesiology in the past generation.
The medicine was approved by the European Commission, following a recommendation last month by an advisory panel in support of the drug, also known as sugammadex.
Bridion was approved for reversal of neuromuscular block induced by the widely used drugs rocuronium and vecuronium.
It was obtained in Schering-Plough's $14.5 billion purchase last year of Organon Biosciences.
Analysts have said that Bridion is one of the biggest advances in anesthesiology in decades and could generate up to $1 billion in annual revenue if it is approved in major markets.
The medicine is awaiting approval in the United States, the world's most lucrative market for prescription drugs. An advisory panel to the U.S. Food and Drug Administration in March voted that it was safe and effective.
In a late stage clinical trial, Bridion reversed the effects neuromuscular blockade within a few minutes- nine to 12 times faster than the standard reversal agent, neostigmine, according to researchers.
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.
Bridion would allow many patients to start breathing on their own far more quickly, and thereby greatly lessen the time needed on ventilatory support and to remain in the recovery room, Schering-Plough has said.
