The FDA announced today that the U.S. Food and Drug Administration approved 35 new medicines in fiscal year 2011. They included “important advances for patients, including: 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.”
The Good News
Highlighting the good news parts of their announcement are the following extracts;
FDA: 35 innovative new drugs approved in fiscal year 2011
FDA NEWS RELEASE
For Immediate Release: Nov. 3, 2011
Report shows quick approvals of safe and effective medicines occur in the United States before other countries
- 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.
Some Perspective
Sansrosa hasn’t even been submitted to the FDA for approval, but when it does, it will need to sit alongside these sorts of drugs, waiting to be approved.
Reading about the sorts of drugs that have been approved and the conditions that they treat, kind of puts the rosacea community’s waiting in perspective a little bit don’t you think ?
We can so easily get tied up in knots obsessing about why new drugs take so long to be approved.
Full Report
For more detailed information about the drugs that the FDA approved see the PDF: FY 2011 Innovative Drug Approvals
