March 11, 2008
FDA Advisory Committee Unanimously Recommends U.S. Approval of Sugammadex, the First and Only Selective Relaxant Binding Agent
KENILWORTH, N.J., March 11 /PRNewswire-FirstCall/ -- Schering-Plough today announced that the U.S. Food and Drug Administration (FDA) Advisory Committee on Anesthetics and Life Support has recommended sugammadex for approval. After reviewing data on the safety and efficacy of the medication, the committee unanimously recommended approval of the company's application for marketing.
The FDA is not bound by the committee's recommendations; however, they usually are considered carefully before a final decision on approval is made.Upon FDA approval, sugammadex will be the first and only selective relaxant binding agent (SRBA) and will give anesthesiologists the ability to rapidly and predictably reverse any depth of muscle relaxation induced by rocuronium and vecuronium within minutes. Sugammadex allows for flexible dosing of muscle relaxation agents enabling anesthesiologists to maintain optimal block through the end of the procedure.
"We are very pleased with the outcome of today's advisory committee meeting and appreciate the panel's careful consideration of the data on sugammadex," said Robert J. Spiegel, M.D., Chief Medical Officer and Senior Vice President, Schering-Plough Research Institute. "Sugammadex has the potential to transform the practice of anesthesia through improved management of muscle relaxation in the millions of surgeries where these agents are used. We will continue to work with FDA to bring sugammadex to the U.S. market as soon as possible so that anesthesiologists and their patients can benefit from this innovative product."
Earlier this year, Schering-Plough announced that the FDA assigned priority review status to the company's New Drug Application (NDA) for sugammadex. In the U.S., priority review is granted to drugs that FDA believes will provide meaningful benefit over existing treatment options.
Sugammadex is specifically designed to reverse the effects of certain widely used muscle relaxants, marketed in the United States as ZEMURON(R) (rocuronium bromide) and vecuronium bromide. Muscle relaxants are used as part of general anesthesia during surgical procedures. Sugammadex works in an entirely novel way to encapsulate the muscle relaxant molecule and restore muscle function so that patients can breathe on their own again. Reversal with sugammadex is generally rapid and can even be used in emergency situations when immediate reversal of rocuronium is needed.
Schering-Plough acquired sugammadex through its combination with Organon BioSciences on November 19, 2007.
Sugammadex is a novel selective relaxant binding agent (SRBA) under development by Organon, a part of Schering-Plough Corporation. Sugammadex was designed to reverse the effects of rocuronium bromide (ZEMURON/ESMERON(R)/ESLAX(R)) or vecuronium bromide, muscle relaxants commonly used during surgeries that require profound muscle relaxation. Anesthesiologists use muscle relaxation to improve surgical conditions, to facilitate intubation and mechanical ventilation, and to reduce the chance of complications.
In clinical trials to date, sugammadex has demonstrated the ability to rapidly reverse shallow and profound depths of rocuronium-induced muscle relaxation, thereby enabling control of the onset and offset of skeletal muscle relaxation through the use of both drugs(1). Sugammadex also has demonstrated the ability to reverse the effects of muscle relaxation induced by vecuronium bromide. The most common adverse reactions (incidence >5%) seen with sugammadex in clinical trials were anesthetic complications generally due to restoration of muscle function (8.0%) and dysgeusia (12.6%).
ZEMURON (rocuronium bromide) is a non-depolarizing muscle relaxant. It was introduced in the United States in 1994 and is one of the most widely used muscle relaxants in the United States, Canada and many European countries (where it is marketed under the brand name ESMERON). It was approved for use in Japan on July 31, 2007, under the brand name ESLAX. To date, it has been used in over 140 million patients worldwide, including an estimated 20 million patients in 2006.
Important Safety Information About ZEMURON
There have been rare reports of severe anaphylactic reactions to ZEMURON (rocuronium bromide) Injection, including some that have been life threatening. Clinicians should be prepared for the possibility of these reactions and take the necessary precautions, including the immediate availability of emergency treatment. ZEMURON Injection should be administered by experienced clinicians who are familiar with the drug's actions and the possible complications of its use. For Full Prescribing Information please go to http://www.zemuron.com/ or http://www.esmeron.com/.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company's ongoing transformation. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com/.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the plans for, the potential of and the potential market for sugammadex. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Item 1A, "Risk Factors" in Schering-Plough's 2007 10-K/A.
Reference: (1) Jones K et al. Faster Reversal of Profound Rocuronium-Induced Neuromuscular Blockade with Sugammadex vs. Neostigmine. Anesthesiology 2007; 107: A1577.
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