- FDA inspectors have said that more sugammadex-injection clinical trial site inspections are needed before this therapy can be considered again for approval. The drug is likely headed for its third FDA rejection.
- Sugammadex injection reverses the effects of muscle relaxants after surgery.
- Merck is expecting a Complete Response Letter (CRL) to arrive by April 27.
About six years ago, the FDA rejected sugammadex based on concerns about safety data, which showed an association between this injectable therapy and bleeding and allergic reactions. Merck has since addressed those concerns; however, new concerns related to the clinical sites used to study sugammadex have cropped up.
What's next? Merck is moving forward, continuing to work with the FDA, waiting for the CRL and eventually resubmitting. One very encouraging factor is that sugammadex is already approved in more than 50 countries and sold under the brand name Brindian.
Plus, there is an unmet medical need for this type of agent, which is designed to make it easier for patients to recover more quickly during the postsurgical period. Analysts predict $550 million in sales by 2020 in the U.S.—assuming that sugammadex is eventually approved.