U.S. FDA advisory meetings through Dec. 15

ANTI-INFECTIVES DRUGS ADVISORY COMMITTEE

DATE: Dec 9, 0800/1300

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

CONTACT: Minh Doan, 301-827-7001

The committee will discuss endpoints and other clinical trial design issues in the development of antibacterial products for the treatment of community-acquired bacterial pneumonia.

ANTI-INFECTIVES DRUGS ADVISORY COMMITTEE

DATE: Dec 10, 0800/1300

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

The committee will discuss a new drug application from Gilead Sciences Inc (GILD.O) for inhaled aztreonam for improvement of respiratory symptoms and pulmonary function in cystic fibrosis patients with Pseudomonas aeruginosa, a bacterial infection.

PEDIATRIC ONCOLOGY SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY COMMITTEE:

DATE: Dec 15, 0800/1300

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

CONTACT: Diem-Kieu Ngo, 301-827-7001

The subcommittee will consider and discuss FDA expectations regarding the development of pediatric formulations for cancer drugs, and the development of dosing regimens in infants and toddlers with cancer.

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. (Reporting by Lisa Richwine and Susan Heavey; Editing by Tim Dobbyn)