FDA approves new drug for Type 2 diabetes
ROCKVILLE, Md. The Food and Drug Administration has approved a new treatment for diabetes.
The FDA announced Friday the approval of Bristol-Myers Squibb’s and AstraZeneca’s Onglyza (saxagliptin), a once-daily treatment for Type 2 diabetes in adults that is designed to be used with diet and exercise to control blood sugar levels.
Onglyza belongs to the class of drugs known as dipeptidyl peptidase-4 inhibitors, also known as DPP-4 inhibitors, which stimulate the pancreas to make insulin after eating a meal. The class also includes Merck & Co.’s Januvia (sitagliptin).
“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”
WellPoint to collaborate with health insurance providers for online tool
INDIANAPOLIS Health insurer WellPoint will collaborate with two other health insurance providers to provide access to its online cost comparison tool for more than 48 million Americans.
The Indianapolis-based insurer said the collaboration would allow Blue Cross Blue Shield of Florida and Health Care Service Corp. – which operates Blue Cross and Blue Shield plans in four other states – to provide the total estimated cost ranges associated with 35 specific medical procedures performed at more than 2,800 hospitals, outpatient surgery centers, free-standing radiology facilities and other facilities.
“We developed this transparency tool in 2006 for use by members in our health plans, with the goal of creating well-informed consumers of health care,” WellPoint president and CEO Angela Braly said in a statement. “We are pleased to be working with other Blue companies so that even more members can have access to clear, concise health cost information in major cities across the country.”
Pfizer, Medivation commence late-stage clinical trial for Huntington disease treatment
NEW YORK Two drug makers have started a late-stage clinical trial of a drug developed by Soviet Union scientists in the 1980s to evaluate it as a treatment for Huntington disease.
Pfizer and Medivation announced Thursday the start of a phase 3 trial of dimebon (latrepirdine), saying that the Food and Drug Administration had granted the drug orphan drug designation. The FDA grants the designation to investigational drugs for conditions that affect fewer than 200,000 people in the United States each year.
The drug was originally developed as an antihistamine, but has attracted the attention of researchers as a possible treatment for Huntington disease and Alzheimer’s disease.
“Based on the promising results of our phase 2 trial of dimebon in Huntington disease, we are pleased to advance dimebon into late-stage clinical development,” Medivation chief medical officer Lynn Seely said in a statement. “Huntington disease is a fatal genetic disease for which no medications are currently approved by the FDA to treat the cognitive impairment associated with the condition.”