The FDA gave itself a proverbial pat on the back in its just-released Innovative Drug Approvals for FY 2012 report, which covers the period Oct. 1, 2011 to Sept. 30, 2012. The agency said that it matched its performance in FY 2011 and approved 35 new medicines during the year.

Commenting on the report in her blog, FDA Commissioner Margaret Hamburg noted that all but one of the medicines was approved within its target review date and "often more quickly than it was done anywhere else in the world." She did point out, however, that the quicker response times were not achieved at the expense of "relaxed review standards regarding patient safety."

The report noted that 34 out of the 35 drugs (97 percent) met the target dates agreed to under the Prescription Drug User Fee Act (PDUFA), surpassing its goal of reviewing and acting on 90 percent of new molecular entities (NMEs) by their target dates.

The FDA said it continues to strengthen its ability to monitor drug safety, and one of the contributing factors for that is the Sentinel Initiative. (See BioWorld Today, July 6, 2011.)

The program is designed to harness a broad network of health care databases to detect and understand drug risks. A pilot program for the initiative called Mini-Sentinel is now able to access electronic health information derived from 159 million patients and perform rapid assessments when there is an early signal that a marketed drug may have a safety problem.

Also, the agency points to its improved ability to process more than a million adverse event reports it receives annually thanks the implementation of their FDA Adverse Event Reporting System (FAERS).

The agency is now approving 77 percent of priority new molecular entities in the first cycle as compared with 46 percent 20 years ago. And the length of the approval phase for a new drug has been cut from an average of two years in 1992 to less than one year today.

Among the 35 NMEs approved in FY 2012 there were a number of firsts including a human cord blood product and drugs to treat advanced basal cell carcinoma and the bone marrow disease myelofibrosis.

Erivedge (vismodegib), which targets the Hedgehog pathway, developed by Roche AG's Genentech unit and Curis Inc. won FDA approval for advanced basal cell carcinoma. (See BioWorld Today, Jan. 31, 2012.)

The first JAK inhibitor, Jakafi (ruxolitinib) from Incyte Corp., was also approved by the FDA to treat the bone marrow disease myelofibrosis. (See BioWorld Today, Nov. 17, 2011.)

Reflecting the industry's interest in rare diseases, approximately one-third of the NMEs approved in the last five years have been drugs for rare diseases. In FY 2012, the FDA approved nine NMEs for rare diseases, the FDA noted.

Also included in the list are two imaging agents. The FDA approved Amyvid (florbetapir F18) for imaging amyloid plaque in the brain, in cognitively impaired patients who may have Alzheimer's disease. The product was developed by Avid Radiopharmaceuticals Inc., a wholly owned subsidiary of Eli Lilly and Co. Inc., of Indianapolis. (See BioWorld Today, April 10, 2012.)

Also approved was Choline C 11 Injection, a PET imaging agent used to help in the detection of prostate cancer.

The Mayo Clinic is the first facility approved to manufacture Choline C 11 , which is manufactured and distributed by the Mayo Clinic PET Radiochemistry Facility in Rochester, Minn.