FDA approves labeling change for Novo Nordisk diabetes drug
PRINCETON, N.J. — The Food and Drug Administration has approved a change to the label of a Novo Nordisk drug stating that it offers superior blood-sugar control to a competing drug made by Merck, based on results of two clinical studies, Novo Nordisk said Monday.
The drug maker announced that the FDA had approved the change for the labeling of Victoza (liraglutide [rDNA origin]) to state that the drug works better than Januvia (sitagliptin) in patients with Type 2 diabetes when either drug is taken with the generic drug metformin. The new labeling also includes data stating the safety and efficacy of the drug when combined with Novo Nordisk’s basal insulin Levemir (insulin detemir [rDNA origin]).
"We’re pleased to expand the Victoza product label to include data demonstrating superior efficacy over Januvia," Novo Nordisk corporate VP diabetes marketing Camille Lee said. "The additional data supporting combination therapy with basal insulin further demonstrates that Victoza is an appropriate option for a wide variety of adults with Type 2 diabetes."
The label change is based on two clinical studies showing that patients who took Victoza experienced reductions in blood sugar of 1.2% to 1.5%, compared with 0.9% in patients taking Januvia, while Victoza also produced greater weight loss — 5.9 lbs. to 7.3 lbs., compared with 1.8 lbs. in the Januvia group. Meanwhile, patients who added Levemir to their Victoza and metformin regimens reduced their blood sugar by a further 0.5%, while 43% of those taking Levemir reached the American Diabetes Association’s blood sugar control target of less than 7%, compared with 17% of those taking Victoza and metformin alone.
Pfizer brings Lipitor marketing campaign to Walgreens Chicago flagship store
CHICAGO — Drug maker Pfizer is taking a marketing campaign for one of its drugs to Walgreens’ Chicago flagship store to raise awareness about high cholesterol and healthy eating, the company said Monday.
Pfizer said it would bring "MasterChef" judge and restaurant owner Joe Bastianich to the store to demonstrate healthy, low-cholesterol cooking using ingredients off the store’s shelves. The event, which takes place Monday afternoon, is part of the drug maker’s "Heart to Health" marketing campaign, which it launched in November 2011 with Bastianich to promote Lipitor (atorvastatin). Lipitor lost patent protection that month, and Ranbaxy Labs now markets a generic version of the drug, which had sales of $7.7 billion in 2011.
"As we transform from a traditional drug store to a destination for health and daily living, we recognize that a quick errand to pick up a prescription or a health and beauty item can also be an opportunity to focus on one’s overall health," Walgreens pharmacist manager Nancy Salman said. "Joe is bringing our flagship store’s new culinary offerings to life, showing our shoppers that they can cook up a quick, delicious and healthy meal with fresh ingredients picked up on the way home."
FDA advisory committee recommends approval for Astellas overactive bladder drug
DEERFIELD, Ill. — A panel of Food and Drug Administration experts has recommended approval for a drug made by Astellas Pharma for overactive bladder.
The drug maker announced that the FDA Reproductive Health Drugs Advisory Committee voted 7-4 with one abstention that its assessment of the risks and benefits of the drug YM178 (mirabegron) supported the drug’s approval.
The FDA is not required to follow the recommendations of advisory committees, but usually does. The agency is expected to decide whether or not to approve the drug by June 29.