Bridion and the Tale of Two Agencies
Once upon a time, there was a promising new drug named Bridion. It was touted by its manufacturer as the first major pharmaceutical advance in the field of anesthesia in two decades. The drug was submitted to two powerful health authorities for marketing approval. Authorization looked like a foregone conclusion as advisory committees for both agencies gave the drug sterling reviews. Financial houses hopped on board and predicted $1 billion in annual sales for Bridion. One agency completed its analysis and determined that the product had proven acceptable safety and efficacy in clinical trials and granted approval. But just days later, unexpectedly, the second agency decided not to accept the unanimous recommendation from its advisory committee and rejected poor Bridion.
Can you guess which agency granted approval and which agency did not? If you’ve been following the pharmaceutical industry for the past five years or so, then you probably guessed that Bridion was approved by the European Commission (EC) and turned down by the FDA. And you’d be right. This isn’t the first time that the FDA has rejected a product that was approved in Europe, but the fact that all signs were pointing toward approval and the fact that the FDA rejected Bridion a mere three days after it was authorized by the EC, makes it a stand-out example of just how cautious the FDA has become.
So why was it a surprise that the FDA rejected Bridion?
First, Bridion (or sugammadex by its generic name) is seen by many as a breakthrough drug in the anesthesia field. Its manufacturer, Schering-Plough, states that “it was specifically designed to reverse within minutes both moderate and deep muscle relaxation induced by rocuronium or vecuronium during general anesthesia. As a result, BRIDION can give anesthesiologists greater control in managing the depth of muscle relaxation through to the end of a surgical procedure.” The drug is able to quickly reduce paralysis induced by anesthesia, allowing doctors to take the patients off breathing tubes in less time and reduce the side effects of being “under” for a long duration, such as undetected loss of oxygen. In clinical trials, Bridion showed an ability to reverse muscle relaxation with a median time under 3 minutes, up to 9 to 12 times faster than neostigmine with glycopyrrolate.
Second, the safety risks had not raised any eyebrows during clinical trials. The most commonly reported adverse effect was a metallic or bitter taste. Some patients experienced anesthetic complications, such as limb movement or coughing during surgery, or unwanted awareness during anesthesia. Other patients experienced allergic reactions, but these reactions did not appear to be any worse than the reactions caused by the most commonly used anesthesia drugs today – neostigmine and succinylcholine. In many physicians’ views, the benefits of faster paralysis reversal far outweighed these safety risks. In fact, the advisory committees for both the FDA and EC performed their respective benefit/risk analyses and gave their recommendations for marketing approval.
Regardless, on August 1, 2008, the FDA rejected Bridion citing concerns about “hypersensitivity and allergic reactions” to the drug. The agency raised no concerns about the drug’s effectiveness. Meanwhile, the first post-marketing patient was treated with Bridion in Sweden last week. The physician reported that the patient experienced reversal from the muscle relaxant used during surgery in just two minutes.
Schering-Plough plans to move forward with its plan to market the product in the U.S., and perhaps the authorization will go a little smoother after the FDA allows the Europeans to be their test subjects for a little while. Maybe the U.S. will see Bridion soon… or maybe not. We’ll have to wait and see.
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