FDA demands REMS for Bydureon
INDIANAPOLIS Drug makers Eli Lilly, Amylin Pharmaceuticals and Alkermes encountered a speed bump in their efforts to win approval for a long-acting formulation of a Type 2 diabetes drug.
The three companies announced Monday that the Food and Drug Administration declined to approve their application for Bydureon, a once-weekly formulation of exenatide, the active ingredient of Byetta.
The FDA cited finalization of product labeling with accompanying risk evaluation and mitigation strategy, or REMS, and clarification of manufacturing processes as its reason for giving the companies a complete response letter for their approval application for the drug. A complete response letter from the FDA means that the review of an application is complete, but the drug is not ready for approval.
“This is a siginificant step forward in our ability to bring this important therapy to patients,” Amylin SVP research and development Orville Kolterman said. “We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks.”
Late-stage clinical trial of Avastin fails to meet expectations, Genentech says
SOUTH SAN FRANCISCO, Calif. A late-stage clinical trial of a Genentech drug for men with late-stage prostate cancer has failed, the biotech company announced Friday.
Genentech, part of Swiss drug maker Roche, announced that a phase 3 trial of Avastin (bevacizumab) combined with prednisone and the chemotherapy drug docetaxel did not extend the amount of time that patients survived, compared with chemotherapy and prednisone alone.
The drug already has approval from the Food and Drug Administration for treating tumors and cancers of the lungs, colon, rectum, breasts, kidneys and brain.
Abbott’s submits supplemental approval application for Lupron Depot to FDA
ABBOTT PARK, Ill. Abbott is hoping that the Food and Drug Administration will approve one of its drugs as a treatment for advanced prostate cancer.
The Chicago-based drug maker announced Thursday that the FDA accepted its supplemental approval application for Lupron Depot (leuprolide acetate) in the 45-mg strength. The drug, an injectable, works by suppressing production of testosterone for six months. It is currently available in 7.5-mg, 22.5-mg and 30-mg formulations that work for one, three and four months.
“For many patients with advanced prostate cancer, Lupron Depot is an important treatment option because it can help manage the symptoms of their disease,” Abbott VP global pharmaceutical development Eugene Sun said in a statement. “Abbott is seeking approval for a new six-month formulation to provide greater convenience and dosing flexibility to physicians and patients who could benefit form this medication.”