FDA accepts NDA for Pozen’s Vimovo
CHAPEL HILL, N.C. The Food and Drug Administration has accepted the regulatory approval application for a drug designed to treat arthritis in patients prone to getting ulcers from their pain relievers.
Pozen announced Monday the FDA’s acceptance of its new drug application for Vimovo (naproxen and esomeprazole magnesium). The drug combines enteric-coated naproxen, a non-steroidal anti-inflammatory drug, or NSAID, with immediate-release esomeprazole, a proton pump inhibitor. It’s designed to treat osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients at risk of developing gastric ulcers associated with NSAIDs.
Osteoarthritis affects nearly 27 million people in the United States, but half of them are at risk from developing ulcers from using NSAIDs to relieve their pain.
Pozen developed Vimovo under an agreement with Anglo-Swedish drug maker AstraZeneca, which will pay Pozen a $10 million milestone payment for the FDA’s acceptance of the application.
Japanese drug maker permitted to start clinical trials of diabetes drug
OSAKA, Japan The Food and Drug Administration has given a Japanese drug maker permission to start clinical trials of a diabetes drug.
Takeda Pharmaceutical Co. announced Friday that the FDA had agreed to the design of a study to examine the effects on cardiovascular safety of the Type 2 diabetes drug alogliptin.
The study will begin next month and end in December 2014, enrolling about 5,400 patients at 1,000 sites in the United States, Europe and Asia.
FDA rejects application for new epilepsy drug
TITUSVILLE, N.J. A drug maker’s regulatory approval application for a new epilepsy drug has been rejected.
Johnson & Johnson announced last week that the Food and Drug Administration had delivered it a complete response letter regarding the drug Comfyde (carisbamate). A complete response letter means that the agency requires additional clinical data before it will approve a new drug or a new use for an existing drug.
J&J filed its application in October, seeking approval for the drug as a treatment for partial onset seizures in patients aged 16 and older.