FDA approves Korlym for Cushing’s syndrome
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.
The FDA announced the approval of Menlo Park, Calif.-based Corcept Therapeutics’ Korlym (mifepristone) for endogenous Cushing’s syndrome, a disorder that results from overproduction of cortisol, a steroid hormone that increases blood-sugar levels.
The drug is approve for patients with the disease who have Type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to surgery, and the agency said about 5,000 patients will be eligible for treatment.
FDA committee recommends approval for obesity drug
MOUNTAIN VIEW, Calif. — A panel of experts at the Food and Drug Administration has recommended approval for an obesity drug that so far had not met much success at the agency.
Vivus announced Wednesday that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of approving Qnexa (phentermine and topiramate) for obesity in adults. The FDA is not bound by advisory committee votes when it decides whether or not to approve a drug, but usually follows them.
"We are pleased with the panel’s approval recommendation in support of the safety and efficacy of Qnexa," Vivus president Peter Tam said. "We look forward to working with the FDA as they complete their evaluation."
The FDA originally accepted Vivus’ regulatory application for Qnexa in February 2010, but the Endocrinologic and Metabolic Drugs Advisory Committee voted 10-6 against recommending approval in July of that year, citing concerns over the safety of the drug. In October 2010, the FDA issued a complete response letter, a notice that it had declined to approve the drug, and requested additional clinical study data.
American Associated Pharmacies partners with RxAlly
SCOTTSBORO, Ala. — American Associated Pharmacies announced that it has partnered with RxAlly, an alliance that includes more than 20,000 pharmacies nationwide that seeks to improve health and reduce costs for pharmacy patients.
"We are actively investing our time, resources and talents in the development of RxAlly," AAP CEO Jon Copeland said. "This is a collaborative effort to better serve our members’ patients and improve the delivery of health care, the likes of which the United States has not seen to date."
AAP is one of largest independent pharmacy cooperatives in America with roughly 2,000 independent pharmacies.