FDA actions
FDA actions
The FDA has approved teriflunomide for the treatment of relapsing forms of multiple sclerosis (MS). The approval was based on a 2-year study in which the drug reduced relapses by nearly a third compared to placebo — results that are about the same as other MS drugs and no better than Merck’s popular injectable interferon beta 1a (Rebif). Side effects include diarrhea, abnormal liver function tests, nausea, and hair loss. It should not be used during pregnancy. Teriflunomide has the advantage of being a once-daily oral medication, the second oral MS medication after Novartis’ fingolimod (Gilenya). Teriflunomide will be marketed by Sanofi Aventis as Aubagio. A third oral MS medication, Biogen Idec’s BG-12, was recently found to reduce MS relapses by about 50% (N Engl J Med 2012;367:1087-1097; 1098-1107). BG-12 is not yet approved by the FDA, but a decision is expected before the end of the year.
The FDA has delayed the approval of apixaban (Eliquis) once again. Pfizer and Bristol-Myers Squibb’s novel oral anticoagulant (NOAC) was expected to be approved last spring after publication of the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial, which showed that the drug was effective in preventing strokes in patients with non-valvular atrial fibrillation — data that suggested that the drug was perhaps even more effective than the two other NOACs, dabigatran (Pradaxa) and rivaroxaban (Xarelto). In June, the FDA told the manufacturers they needed "additional information on data management and verification from the ARISTOTLE trial." Now, the agency says that the review date will be March 17, 2013. No reason was given by the FDA for the delay.
About 25% of Internet consumers have purchased prescription medications online, while at the same time, the prevalence of fraudulent Internet pharmacies has grown. The FDA has now launched a national campaign to raise public awareness called BeSafeRx Know Your Online Pharmacy, a resource that provides patients and caregivers with a better understanding of who they are buying from, and makes sure the medication they buy matches what their doctor prescribed. The FDA recommends that patients only buy medications from online pharmacies that require a prescription, are located in the United States, have a licensed pharmacist available for consultation, and are licensed by the patient’s state board of pharmacy. More information can be found at www.FDA.gov/BeSafeRx.
The FDA has approved enzalutamide to treat men with late-stage, castration-resistant prostate cancer under the agency’s priority review program. The drug was approved based on a study of nearly 2000 men with metastatic prostate cancer who had been previously treated with docetaxel. Men treated with enzalutamide lived an average of 18.4 months vs 13.6 months for men treated with placebo. Enzalutamide is co-marketed by Astellas and Medivation as Xtandi.
The FDA has also approved a new agent for the treatment of advanced colorectal cancer. Regorafenib is a multi-kinase inhibitor that was also approved under the FDA’s priority review program. In a study of 760 patients with previously treated metastatic colorectal cancer, regorafenib extended survival about 45 days to 6.4 months from 5 months for placebo as well as progression-free survival of 2 months vs 1.7 months for placebo. Regorafenib is marketed by Bayer as Stivarga.