FDA approves Novo Nordisk’s Victoza for Type 2 diabetes
ROCKVILLE, Md. The Food and Drug Administration has approved a long-awaited treatment for Type 2 diabetes, the agency announced Monday.
The FDA approved Novo Nordisk’s Victoza (liraglutide), a once-daily injection for adults. The drug belongs to the class known as glucagon-like peptide-1 receptor agonists, which also includes Eli Lilly & Co.’s and Amylin’s Byetta (exenatide).
“Diabetes is a leading cause of death and disability, with more than 1.5 million new cases diagnosed annually,” FDA Center for Drug Evaluation and Research Division of Metabolism and Endocrinology Products director Mary Parks said in a statement. “Controlling blood sugar levels is very important to preventing or reducing the long term complications of diabetes, and Victoza offers certain patients with Type 2 diabetes a treatment option for controlling their blood glucose levels.”
Novo Nordisk heralded the news, saying it would introduce Victoza into U.S. markets “within weeks.”
“The U.S. approval of Victoza represents a major advancement in the treatment of Type 2 diabetes and is an important milestone for Novo Nordisk that follows the recent approval in Japan and the ongoing successful launch in Europe,” Novo Nordisk president and CEO Lars Rebien Sorensen said. “We are convinced that Victoza will prove to be a valuable treatment option for people with Type 2 diabetes in the U.S. The ability of Victoza to substantially improve glucose control with a low risk of hypoglycemia creates an opportunity for more patients with Type 2 diabetes to achieve their individual treatment goals.”
Report; N.Y. seeks to prohibit doctors from accepting gifts from drug companies
ALBANY, N.Y. New York Gov. David Paterson hopes to put an end to gifts from drug companies to doctors, according to published reports.
The Associated Press reported Sunday that Paterson proposed legislation that would prohibit drug makers from giving doctors such gifts as pens and free meals to persuade them to prescribe their drugs. Drug companies that violated the ban would be fined between $15,000 and $250,000, while healthcare professionals would be fined $5,000 to $10,000. Nine states so far have laws on the books that prohibit the practice.
According to the AP article, patient-advocacy organizations such as AARP are supporting the legislation, while the Pharmaceutical Research and Manufacturers of America, which represents the branded drug industry, opposes it.
Acorda appoints EVP commercial development
HAWTHORNE, N.Y. The founder of a consulting firm has joined the executive board of Acorda Therapeutics, the drug maker announced Monday.
Lauren Sabella will work as Acorda’s EVP commercial development, reporting to president and CEO Ron Cohen and assuming responsibility for Acorda’s commercial operations such as marketing, sales and managed markets.
Before working for Acorda, Sabella was founder and principal of Tugboat Consulting Group, which assisted companies in commercialization. She also worked as VP commercial development for Altus Pharmaceuticals and served in various positions at Boehringer Ingelheim Pharmaeuticals for 18 years.
“I’m delighted to welcome Lauren Sabella to Acorda’s management team,” Cohen said. “Lauren has an impressive record of achievement in the pharmaceutical industry, including responsibility for launching and managing several high-performing products.”