FDA Rejects Schering-Plough's Anaesthetic Drug Sugammadex NDA

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 05 Aug 2008 - 0:00 PDT

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The U.S. FDA has issued a non-approvable letter to Schering-Plough regarding the U.S. firm's New Drug Application (NDA) for sugammadex sodium. The product (also marketed under the brand Bridion) is a selective relaxant binding agent that reverses the effects of neuromuscular blockade by rocuronium in general anaesthesia. In a press statement, Schering-Plough has said that the FDA's concerns over the drug are related to hypersensitivity or allergic reactions. No issues related to the efficacy of the drug have been mentioned by the agency. Schering-Plough acquired the drug after purchasing biopharmaceutical firm Organon Biosciences in November 2007, and has since touted the experimental product as one of its main gains. Schering has noted that the product is the first innovation in two decades in the anaesthesia segment, and has committed to working with the FDA to resolve the issues behind the rejection.

Meanwhile, the company's cholesterol product Vytorin was once again under the spotlight. The U.S. House Energy and Commerce Committee has asked the FDA to publish details of the findings on a study conducted to examine the product's cancer risk, Reuters reports. The study found a higher cancer risk associated with patients taking Vytorin at 39 and with patients on a placebo at 23 in the closely monitored trial.

Outlook and Implications

The rejection will be a setback for Schering-Plough - more in terms of investor confidence in the short term. The company has had a series of run-ins with regulatory agencies since cholesterol drug Vytorin and Zetia (ezetimibe/simvastatin and ezetimibe) were linked to potential adverse safety issues. However, the development is fairly surprising given that an FDA panel gave it a confident go-ahead in March. However, although the committee gave its approval, it did cite concerns over allergy reactions. Nevertheless, the approval was unanimous. Further, the company gained European Commission approval for marketing the drug in the European Union (EU) as Bridion. For Schering-Plough, the development will delay the realisation of the benefits the U.S. firm obtained when it acquired Organon Biosciences.

From a regulatory perspective, the product is the fourth in the list of rejected applications from the FDA that is associated with Big Pharma firms. Notably, the regulatory agency had rejected Merck & Co's (U.S.) Cordaptive/Tredaptive (nicotinic acid/laropiprant), Merck and Schering-Plough's respiratory combination drug Claritin and Singulari (loratidine and montelukast), and Eli Lilly's (U.S.) long-acting version of schizophrenia drug Zyprexa (olanzapine), mainly due to safety concerns. The rejection will put the agency's conservative approach to NDAs under the spotlight. Global pharmaceutical majors have already noted that the number of FDA approvals has reduced, triggered by the withdrawal of Merck's Vioxx (rofecoxib) over safety concerns. The agency is under increasing pressure from the U.S. government, leading to a tightening of criteria for NDA approvals.

http://www.schering-plough.com