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.
Mylan launches generic version of Detrol LA
PITTSBURGH — Mylan has launched a generic version of a drug made by Pfizer for treating bladder problems, the company said Tuesday.
Mylan announced the launch of tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths. The drug is used to treat overactive bladder with symptoms of urinary incontinence, urgency and frequency.
The drug is a generic version of Pfizer’s Detrol LA. Tolterodine tartrate extended-release capsules had sales of about $571.5 million during the 12-month period that ended in September, according to IMS Health.