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Byetta Fallout Hits Novo Nordisk (That Pancreatitis Scare)
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.”
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.
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All of this comes from the FDA’s reliance on HbA1c as a “surrogate” for improved patient outcomes, rather than a true long-term measure of any new drug’s effectiveness. Earlier this year, the FDA concluded after several open solicitations for input and meeting with the Cleveland Clinic’s Dr. Steve Nissen that the use of “surrogates” had lead the agency to approve a number of drugs which did not improve patient outcomes, but merely lowered blood glucose levels — which by itself is not a guarantee of improved outcomes. Today, the FDA is FINALLY moving more cautiously and we’re finally starting to see some of that outcome. Novo has been on overdrive with press releases and mis-representative data (for example, recently, the company admitted that liraglutide DID cause cases of pancreatitis, but the company tried to spin things by noting that it was, in their words, “not a statistically significant increase”). The reality is that these changes are long overdue, for too long, regulators have allowed the needs of the drug industry take precedence over the need for protecting patient safety. We can hope regulators make Novo’s approval much more difficult, as it will really change the mode of operation for an industry which has learned to selectively disclose facts to gain approvals, but in fact, provide only marginal incremental patient benefits.
Posted by: Scott | September 5th, 2008 at 11:05 amThis is unfortunate. So many have really high hopes for this drug. One of the reasons I’ve always tried not to get too upset about the price of drugs is the hope that quality is job one, but more and more of these cases make me think that marketing is job one.
In addition, the FDA’s involvement in the markets and the corresponding price elevation from supply control seems to be a total waste since the quality that is supposed to result from that involvement seems to be waning.
Posted by: Glucoholic | September 5th, 2008 at 5:26 pmI initially thought the article was optimistic but its final discussion was quite pessimistic. too bad!!!
Posted by: Sharod Broadhead | September 7th, 2008 at 5:28 amThe opulent menus of sugar meds some doctors use to prescribe their diabetics (just read some forums - I do not want to know what else they must take for the rest of their ailments) before they top them with Byetta sort of curls my toenails. - Looks like at least “some” health professionals don’t read and respect med specifications, doesn’t it?
Posted by: Hans | September 7th, 2008 at 1:09 pmI must say that when I first started on Byetta I was a bit concerned but when I started to lose weight I hailed it as a GREAT medication - BUT I was also getting very sick every time I injected it (2x’s a day) After 4 months of being “sick”, throwing up every day - I became very ill and had become so dehydrated and my BS numbers blew up to over 500 when I was finally put in the hospital. Very scary situation and it amazed me that my doctor did not even question that the side effects of the Byetta had caused this.
Posted by: Kathy | September 10th, 2008 at 8:42 amI stopped takking it and thankfully from being so sick I had lost a little over 20lbs and my BS levels had dropped. I no longer take Byetta and feel great, no more stomach pain and nausea. I did try going back on it recently but after the FIRST injection I was sick right away!
I feel the drug companies are putting out these new “wonder” drugs and hailing all the great benifits of them LONG before they have been tested long enough. People should not die before the public heeds the warnings of the dangers of these drugs.