[acb-diabetics] long term injections of byette FMay cause cancer

[Patricia LaFrance-Wolf]

Print | 

Category | 

Home 

Previous | 

All Articles This Week | 

Next 

This article originally posted 13 April, 2010 and appeared in  

Issue 517

 

Amylin, Lilly's Byetta May Have Cancer Risk, FDA Says

 

Amylin Pharmaceuticals, Inc., and Eli Lilly & Co.'s long-acting Byetta may
be tied to increased cancer risk, a top U.S. regulator said, raising
concerns

that the experimental diabetes drug may need strict warnings....

 

Advertisement 

 

Click here to find out more! frame

 

Flash movie start

Flash movie end

Click here to find out more! frame end

 

Data on intravenous dosing and a once-weekly version of Byetta "seem to give
a similar signal" as cancers seen in rodent studies of Novo Nordisk A/S's
competing

Victoza, said Curtis Rosebraugh, head of the Food and Drug Administration's
Office of Drug Evaluation II, in a Jan. 25 memo posted on the agency's
website.

 

Victoza was approved in January after 10 months of delay because of safety
concerns. During that review, the FDA said tumors may be common with all
extended-release

diabetes drugs in a family of medicines known as GLP-1 analogs, a class that
includes Byetta and Victoza. The new memo is the first indication that
long-acting

Byetta will carry the same boxed warning, the agency's strictest caution, as
Victoza.

 

When the long acting LAR version of Byetta gets approved by the FDA, there
may be a similar black box warning about cancer and that is likely to
dissuade

some generalist physicians from adopting the long-acting GLP-1s, and
therefore will make it somewhat harder for the class to achieve the growth
that was

assumed.

 

The FDA delayed a decision on a proposed once-weekly version of Byetta on
March 15 and asked for more information on manufacturing, labeling and a
risk-management

plan. No new studies were ordered for the product, to be called Bydureon.
Technology for the long-acting version was developed by Alkermes Inc., of
Waltham,

Massachusetts.

 

Novo Nordisk's Victoza, a daily shot chemically known as liraglutide, isn't
recommended by the FDA as an initial treatment for diabetes. The FDA ordered

the Bagsvaerd, Denmark-based company to conduct additional studies to assess
a potential risk of thyroid tumors.

 

"Our internal data indicates that the preclinical findings are not unique to
liraglutide but will probably extend to all" similar long-acting diabetes
drugs,

the FDA's Rosebraugh said in the memo included in Victoza's approval
package. "So to condemn liraglutide would be to condemn them all."

 

Amylin said in a statement that the new report does not contain any new data
on Byetta or Bydureon. The company noted that more than 1 million patients

have used Byetta, with no signs of cancer.

 

Rats that received 25 times the human dose of Bydureon showed statistically
significant risk of thyroid cancer, but the company said that result is "of

uncertain significance to humans."

 

"A relationship between Bydureon and human thyroid cancer has not been
established, but cannot be ruled out," the company said. "As is the case
with any

drug therapy, continued follow-up is warranted."

 

-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://www.acb.org/pipermail/acb-diabetics/attachments/20100418/9f307eab/attachment-0001.htm>