FDA on a hot streak

U.S. regulators approved a record number of new drugs in 2012

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WASHINGTON, D.C.—Although the number of new drugs approvedby the U.S. Food and Drug Administration (FDA) rose to a 15-year high lastyear, there have been several high-profile denials so far in 2013, according toa recent announcement made by the regulatory agency.
The FDA approved a total of 35 novel drugs in 2012. In thelast decade, the FDA averaged about 23 approvals per year. According to manyanalysts, these approvals are likely to increase with the passage of thePrescription Drug User Fee Act (PDUFA).
The 35 new drugs approved last year included agroundbreaking treatment for a form of cystic fibrosis, the first human cordblood product ever approved and the first drugs to treat advanced basal cellcarcinoma—a form of the most common skin cancer—and the bone marrow diseasemyelofibrosis.
Notably, oncology drugs were the highest category of newapplications approved, as the agency signed off on 10 new cancer drugs,including Xtandi (Medivation) for late-stage prostate cancer; Erivedge(Genentech) for late-stage skin cancer; Jakafi (Incyte) for myelofibrosis;Voraxaze (BTG International) to lower toxic levels of the chemotherapy drugmethotrexate; Erwinaze (EUSA Pharma) for acute leukemia; Stivarga (BayerHealthcare Pharmaceuticals) for late-stage colorectal cancer; Perjeta(Genentech) for late-stage breast cancer; and Bosulif (Pfizer) for chronicleukemia.
Other diseases benefitting from approvals were cysticfibrosis, HIV, macular degeneration, Alzheimer's disease, blood disorders,meningitis and Gaucher disease.
The FDA attributed its expedited reviews and approvals toseveral review authorities for new drug applications, including Fast Track,Priority Review and Accelerated Approval. In addition, "strengthenedcommunication with drug companies early in development and flexible clinicaltrial designs for drugs for unmet medical needs" also enabled drug companies toconduct shorter, smaller or fewer studies, reducing the length and cost of drugtesting, the FDA said.
"As in previous years, FDA's record in FY 2012 shows itscommitment to helping patients get timely access to important new drugs," theagency said in a statement. "The timeliness of FDA approval of new drugscontinues to compare favorably with other regulatory agencies around the world.While we are not in competition with them, we recognize the need to approvesafe and effective drugs that offer new health benefits as quickly as possible."
Nevertheless, the FDA made headlines in the first few monthsof this year for several high-profile application rejections. In late January,Impax Laboratories Inc. were denied approval for Rytary, the company'sParkinson's disease drug. The FDA requested a reinspection of its manufacturingfacility. Impax's efforts to get the drug approved may be delayed by about ayear.
In February, Denmark-based Novo Nordisk's new drugapplications for insulin drugs Tresiba and Ryzodeg were denied. The FDArequested additional cardiovascular data from a dedicated cardiovascularoutcomes trial before the review of the applications can be completed. NovoNordisk said it does not expect to be able to provide the requested data during2013.
And on March 4, an FDA advisory panel recommended that theagency reject a drug for hot flashes associated with menopause made byHisamitsu Pharmaceutical Co. Inc.'s subsidiary, Noven Pharmaceuticals Inc. Thepanel voted 10-4 against approval, with the majority saying the drug's benefit wasnot sufficient to offset its risks. The panel was evenly divided over whetherthe drug was in any way effective.

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