This morning Novo Nordisk announced that the FDA has scheduled an advisory committee meeting for its new Liraglutide once-daily GLP-1 drug, currently awaiting FDA approval. Believe it or not, this is huge news — with the potential to make or break a multi-billion-dollar diabetes drug category and set the tone for FDA safety proceedings in years to come.
What the FDA has done is to push off approval of Novo's new Type 2 diabetes drug, over safety concerns associated with the incredibly successful GLP-1 drug Byetta, which may or may not be causing pancreatitis in a number of patients. (I know lots of patients who've lost significant weight and flourished on Byetta.)
Quick background: Novo's Liraglutide is the first human Glucagon-Like Peptide-1 (GLP-1) analogue developed for the treatment of Type 2 diabetes. It works by stimulating the release of insulin only when glucose levels become too high and by inhibiting appetite. It has the potential to help this new class of drugs become a core treatment and a multi-billion-dollar market.
But instead of sailing through FDA approval, as seemed the case during June's ADA Conference, when GLP-1's where "the hottest thing going," Novo will be required to participate in a rare Advisory Panel Meeting on March 9, 2008, in Washington, DC. A committee of 10-20 experts will present evidence as to whether GLP-1 drugs are potentially dangerous enough to warrant a "black box warning" on product labels.
"If that happens, the drug is pretty much dead," says David Kliff of Diabetic Investor, one of the country's best-known diabetes industry analysts. "But from all the discussions I've had with experts, we think this is an overblown concern. We don't believe there is a causal relationship between Byetta usage and pancreatitis. The incidence rate of pancreatitis in Byetta users is actually LOWER than in the general population, and also, people with diabetes are at greater risk of developing pancreatitis just because they have diabetes."
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Still, the panel meeting is going to be "really, really, really interesting," Kliff tells me, because the tone of the questions and the way testimony is handled will have a ripple effect throughout the industry. All of the big players -- Amylin, Eli Lilly, Roche, etc. -- will be watching the proceedings carefully. The panel will conduct a thumbs up-and-down vote right on-site. But the FDA is not obligated to follow their recommendations, and has in fact crossed them in the past.
"Novo could go for the knockout punch and claim that the pancreatitis issue is limited to Byetta," Kliff writes in a news advisory today. But more likely they'll take the mainstream route that pancreatitis associated with GLP-1 usage is "a rare and uncommon event." Indeed that seems to be the case. "Unless the FDA knows something the public doesn't know," Kliff adds. Hmmm, let's hope not.