This is not good news for Eli Lilly or its partner, Amylin Pharmaceuticals, which are counting on their once-weekly version of the Byetta diabetes treatment to become a much-needed blockbuster. A Jan. 25 memo written by an FDA official notes that data suggests the med appears to "give a similar signal" as cancers seen rat studies of Novo Nordisk's competing Victoza.
Victoza, you may recall, was approved in January after nearly a year's delay over safety concerns. At the time, the agency noted that thyroid tumors may be common with all extended-release diabetes drugs in a group of meds known as GLP-1 analogs, which includes Byetta and Victoza. Last month, the FDA delayed approving the new Byetta and sought more info on labeling and a risk-management plan, although new studies weren't required.
The memo (which you can read here) was written by Curtis Rosebraugh, who heads the FDA’s Office of Drug Evaluation II and Phil Nadeua, a Cowen & Co. analyst tells Bloomberg News this appears to be the first indication that the new version of Byetta will carry the same boxed warning as Victoza.
A Lilly spokeswoman wrote Bloomberg that a relationship between the new Byetta, to be called Bydureon, and human thyroid cancer hasn't been established, but can't be ruled out, and added that a statistically significant increase in thyroid cancers was seen in female rats given doses 25 times greater than people take.
photo courtesy of asplosh at flickr creative commons
8 Comments
Curious how risks such as these rarely stop the FDA from granting marketing approvals. And once granted FDA approval, removal of a drug from the marketplace is extraordinarily rare. As if the risk of necrotizing hemorrhagic pancreatitis is not enough. Now cancer risks. Makes one wonder who is looking out for the public's health and safety. Certainly not our FDA. All FDA is really doing is complying with expedited review timelines under the PDUFA and serving their biggest client...pharma.
That is a ridiculous comment and a very biased article. The FDA spokesman here was only defending their position to approve Victoza, and probably overspoke as to any risk of byetta/bydureon causing cancer. It has not been demonstrated in clinical trials nor has there been any link to a cancer risk after 5 years byetta has been on market. As for that pancreatitis risk comment, that was shown to be not so true either, with a major data study demonstrating that byetta is no more likely to be a causal agent of pancreatitis than any other drug to treat type II diabetes, and in fact, diabetics are more prone to get pancreatitis than any other individuals. Oh the level of disinformation as to such risks are shameful! I bet the previous comment was by a law firm or hedge firm trying to place fear on someone using the drug and drive down the price of the company stock.
@ CMike,
Do you have any disclosures you might wish to make?
Res ipsa loquitor..."the thing speaks for itself".
http://www.newsinferno.com/archives/3656
http://www.drug-injury.com/druginjurycom/2008/08/august-2008-byetta-associated-with-hemorrhagic-pancreatitis-and-necrotizing-pancreatitis.html
http://www.adrugrecall.com/byetta/hemorrhagic-pancreatitis.html
http://www.medpagetoday.com/ProductAlert/Prescriptions/6998
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190406.htm
http://www.diabeteshealth.com/read/2008/08/28/5887/byetta-takes-a-beating-as-feds-question-its-safety-defender-chides-fda-for-bureaucracy-and-bad-scien/
When I started in clinical development 28 years ago, companies were required to complete and evaluate the results of two year carcinogenicity studies BEFORE first time in humans. Cancers in both sexes and two species of rodents would have definitely stopped development right there in its tracks, before the first human subject swallowed the first pill. These days companies are allowed to go into clinicals before completion of animal carcinogenicity studies.
Here is a not uncommon scenario: Youve already spent several hundred million dollars on your potential blockbuster, and are in the middle of Phase III studies when you get the bad news from the head of pharm/tox. Your next three phone calls (in no particular order) are 1) Regulatory Affairs to begin the strategizing on how to get the drug approved despite strong carcinogenicity data, 2) Corporate Legal to give them a heads-up for potential product liability lawsuits, and 3) the Marketing VP, to tell him/her to cancel the launch meeting. A fourth call might go to a media company for advice on crisis management.
Thank you, Vet. You've stated the problem very well.
"Last month, the FDA delayed approving the new Byetta and sought more info on labeling and a risk-management plan, although new studies weren’t required."
See this link to the FDA NDA approval/supplemental approval letter from Mary Parks, M.D. (CDER) which requires postmarketing safety studies of Byetta. Have these studies been completed and published, e.g. studies 1559-2 and 1559-3 ?
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf
Where are the postmarketing safety studies of Byetta which were required under subsection 505(k)(1) of the FDCA?
By November 30, 2009, an adequately powered epidemiological study WAS REQUIRED [OF AMYLIN] BY FDA to determine the incidence rate, severity and risk factors for the development of acute pancreatitis, including the more severe forms of hemorrhagic and necrotizing pancreatitis, in exenatide-exposed versus unexposed patients.
By March 31, 2010, epidemiologic queries using i3 Aperio WAS REQUIRED [OF AMYLIN] BY FDA to assess the relative risk of pancreatic cancer and thyroid neoplasm among patients using Byetta and those using metformin or glyburide. Thyroid neoplasm assessment will also include benign and malignant diagnosis event stratification.
Were these studies not conditions upon which the FDA based its approval? Where are they? Can someone provide a link to the studies? I'd be grateful for them. Thanks.
Well yes patron you are right. i am totally agree on this. i guess FDA should not approve such things. its too problematic to recall the from market.