U.S. FDA advisory meetings through Dec. 18

ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE

DATE: Dec 15, 0800/1300

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: Paul Tran, 301-827-7001

The committee will discuss a supplemental new drug application from AstraZeneca (AZN.L) for Crestor. The proposed use of Crestor in this application is primary prevention of cardiovascular disease based on the results of JUPITER. JUPITER was a clinical trial that studied individuals who did not have obvious or overt cardiovascular disease but did have the following characteristics: Low or normal levels of LDL cholesterol; elevated levels of C-reactive protein and at least one of the conventional risk factors for cardiovascular disease. In these individuals, JUPITER evaluated the reduction of risk with Crestor therapy on the study's combined objectives, which included death from heart attack or stroke, non-fatal heart attacks and strokes, unstable angina and heart or blood vessel disease that necessitates bypass surgery.

EAR, NOSE AND THROAT DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE

DATE: Dec 18, 0800/1300

LOCATION: Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, Md.

CONTACT: James Kane, 301-796-6477

The committee will discuss, make recommendations and vote on a premarket approval application, sponsored by privately held Envoy Medical Corporation, for the Esteem Totally Implantable Hearing System. The Esteem is a totally implantable hearing device that is implanted in the middle ear to help hearing in patients suffering from mild to severe hearing loss that is sensorineural in origin. The Esteem System consists of three implantable components (sound processor, sensor and driver), two external programmers (Esteem Programmer and Personal Programmer), an external Intraoperative System Analyzer and accessories. The intended use of the Esteem is to alleviate hearing loss in adults by replicating the ossicular chain and providing additional gain. (Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn)