Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines for patients, like two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.
FY 2011 Innovative Drug Approvals – In this report, FDA provided details of how it used expedited approval authorities, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to boost the number of innovative drug approvals to 35, while drug safety standards have been maintained.
“Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients,” said Margaret Hamburg, M.D., Commissioner of Food and Drugs.
Important points of the report – FY 2011 Innovative Drug Approvals:
? Two of the drugs ? one for melanoma and one for lung cancer ? are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits;
? Seven of the new medicines provide major advances in cancer treatment;
? Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection;
? Ten are for rare or “orphan” diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema;
? Almost half (16) were approved under “priority review,” in which the FDA has a six month goal to complete its review for safety and effectiveness;
? Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information;
? Three were approved using “accelerated approval,” a program under which the FDA approves safe and effective medically important new drugs quickly, and relies on subsequent post-market studies to confirm clinical benefit. For example, Corifact, the first treatment approved for a rare blood clotting disorder, was approved under this program; and
? Thirty-four of 35 were approved on or before the review time targets agreed to with industry under PDUFA, including three cancer drugs that FDA approved in less than six months.
Source: U.S. Food and Drug Administration, USA