Daiichi Sankyo hopes to get FDA nod for anti-clotting drug
PARSIPPANY, N.J. — Japanese drug maker Daiichi Sankyo is seeking Food and Drug Administration approval for a once-daily tablet to reduce the risk of stroke in patients with atrial fibrillation and treatment of other conditions.
Daiichi Sankyo announced the submission of a new drug application for Savaysa (edoxaban). The company also is hoping to get the FDA’s approval for the pill as a treatment for deep vein thrombosis and pulmonary embolism, as well as preventing the recurrence of symptomatic venous thromboembolism.
"The NDA submission in the United States is an important milestone in the development of edoxaban and reflects our long-standing commitment to addressing the needs of patients living with cardiovascular disease, including those living with AF or VTE," said Daiichi Sanko senior executive officer and global head of research and development Glenn Gormley. "If approved, edoxaban may provide a new treatment option for physicians and their patients with these diseases."
FDA approves Bristol-Myers Squibb’s, AstraZeneca’s Farxiga
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Bristol-Myers Squibb and AstraZeneca for treating Type 2 diabetes, the agency said Wednesday.
The FDA announced the approval of Farxiga (dapagliflozin) tablets, designed for use with exercise and dietary adjustments to control blood sugar. Type 2 diabetes affects about 24 million people in the United States, accounting for more than 90% of diabetes cases.
"Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans with Type 2 diabetes," FDA Office of Drug Evaluation II director Curtis Rosebraugh said.
The drug belongs to a class known as sodium-glucose co-transporter 2, or SGLT2, inhibitor. The drug works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion and thereby lowering blood glucose levels.
Takeda starts phase-3 trials of vedolizumab
OSAKA, Japan — Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.
Takeda announced the start of two phase-3 trials of MLN0002 (vedolizumab) in patients with severe ulcerative colitis and Crohn’s disease. The trials are designed to find out the efficacy, safety and effects on the body of the drug, particularly to see if patients show a response after 10 weeks of treatment and disease remission after 60 weeks.
"Many patients suffering from ulcerative colitis and Crohn’s disease are eagerly awaiting new treatment options," Takeda VP general medicine Asit Parikh said. "We are striving to accelerate the development of this drug to deliver this effective and highly anticipated treatment option for patients in Japan as soon as possible."
Takeda submitted a regulatory approval application to the Food and Drug Administration for the drug in June 2013.