FDA approves Merck diabetes drug
WHITEHOUSE STATION, N.J. — The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said Thursday.
Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.
"Janumet XR is a new treatment that adds once-daily convenience to the powerful efficacy of Janumet for patients with Type 2 diabetes," Merck VP diabetes and endocrinology Barry Goldstein said. "This is important because many patients with Type 2 diabetes require treatment with multiple drugs to maintain blood-sugar control, and Janumet XR is a new option to help more patients get to their glucose goals."
PhRMA: More than 50 drugs in development for COPD
WASHINGTON — More than 50 drugs are under development for treating a respiratory disease that is the third-leading cause of death in the United States.
The Pharmaceutical Research and Manufacturers of America released a list Thursday of 54 drugs in clinical development for chronic obstructive pulmonary disease, or COPD.
COPD, which includes chronic bronchitis and emphysema, affects more than 13 million adults in the United States and causes obstructed airflow to the lungs, and the number of people with the disease is increasing, according to the National Institutes of Health, which estimated that 12 million may have the disease without knowing it.
"Early detection of COPD is imperative, as effective treatment can change the course and progression of this devastating disease," PhRMA president and CEO John Castellani said. "The promising new therapies highlighted in this report illustrate how emerging scientific approaches to treatment respiratory diseases, such as COPD, offer great hope to improve and save the lives of future patients."
The new drugs include a medicine that targets the underlying inflammation in COPD, a biotech drug that acts on the biological processes involved in the disease’s inflammatory component and an adult stem cell therapy that targets a protein in the blood often elevated in patients with the disease, PhRMA said.
Mylan wins tentative approval for generic Lipitor
PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.
Mylan announced that it had received tentative approval for a generic version of Pfizer’s Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths.
A tentative approval means that the drug meets the FDA’s conditions for approval, but the agency can’t give final approval because of outstanding patent- and exclusivity-related issues. Ranbaxy Labs, which won approval for the first generic version of the drug in November, currently has the exclusive right to compete with Pfizer’s version and will until May.
Lipitor had sales of $8.2 billion in 2011, according to IMS Health.