FDA Approves Amylin's Bydureon Diabetes Drug After Delays
28 January 2012 - 8:12AM
Dow Jones News
The U.S. Food and Drug Administration approved Amylin
Pharmaceuticals Inc.'s (AMLN) diabetes drug Bydureon following a
prolonged regulatory process in which the agency required extra
testing to alleviate safety concerns.
The agency approved the drug to treat adults with type 2
diabetes, the most common form of diabetes, according to a letter
posted on the FDA website Friday afternoon. An FDA spokeswoman
confirmed the approval.
The FDA-approved prescribing label for Bydureon has a prominent
warning stating that the drug caused thyroid C-cell tumors at
clinically relevant exposures in testing in rats, according to the
FDA website.
The warning notes that it's unknown whether the drug causes such
tumors in humans. But it says Bydureon shouldn't be used in
patients with a personal or family history of medullary thyroid
carcinoma.
Bydureon is a once-weekly injection to treat type 2 diabetes.
It's an extended-release version of Amylin's older diabetes drug,
Byetta, which is injected twice daily. Bydureon, which uses
exenatide as its active ingredient, was approved for sale by
European regulators in June.
The drug is designed to work by helping the body to make more
insulin, which can reduce high blood-sugar levels.
Some analysts have estimated Bydureon sales could reach nearly
$2 billion annually by the end of this decade. But it will face a
crowded market, as drug companies have responded to the rising
incidence of diabetes worldwide by developing new treatments.
Bydureon's road to FDA approval was a bumpy one, along which
Amylin severed its longstanding diabetes-drug partnership with Eli
Lilly & Co. (LLY). Amylin first began working on Bydureon in
1999.
The original plan was for Lilly and Amylin to co-promote
Bydureon in the U.S., with Lilly handling markets outside the U.S.
The companies had a similar arrangement for Byetta, which was
approved by the FDA in 2005.
Lilly and Amylin submitted Bydureon for FDA approval in May
2009, based on clinical-trial data showing it improved measures of
blood sugar versus Byetta. Addressing heightened FDA scrutiny of
heart-related effects of diabetes drugs, the companies said at the
time that an analysis showed no increased risk of cardiovascular
events to be associated with exenatide.
The FDA initially declined to approve it, asking in March 2010
for more information about the drug's prescribing label and the
companies' risk-management plan to ensure the drug's benefits
outweigh its risks. Amylin and Lilly were optimistic they would get
FDA approval later in 2010 after providing the requested
information.
However, in October 2010, the FDA dropped a bombshell by
rejecting Bydureon again. This time the agency asked for a new
study to test the effect of a high dose of the drug on heart
rhythm.
The companies ran the required test and in June said results
showed Bydureon wasn't associated with a clinically relevant
prolonged measure of heart rhythm. The results increased optimism
that the drug would finally get an FDA green light.
Amid the delay, the partnership between Lilly and Amylin
deteriorated, and ultimately was terminated. In January 2010, Lilly
formed a new diabetes-drug partnership with Boehringer Ingelhiem
GmbH, prompting Amylin to file a lawsuit alleging breach of its own
contract with Lilly.
In November, Lilly and Amylin settled the dispute by agreeing to
return global development and commercialization rights for Byetta
and Bydureon to Amylin. Lilly will receive royalties on sales of
Byetta and Bydureon up to a cap.
Amylin is manufacturing Bydureon with extended-release
technology provided by Alkermes Inc. (ALKS).
Shares of Amylin and Alkermes were halted Friday in advance of
the agency decision.
Spokesmen for Amylin and Alkermes couldn't immediately be
reached.
-By Peter Loftus, Dow Jones Newswires; 215-982-5581;
peter.loftus@dowjones.com
(Jennifer Corbett Dooren contributed to this article.)
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From Apr 2024 to May 2024
Amylin Pharmaceuticals, Inc. (MM) (NASDAQ:AMLN)
Historical Stock Chart
From May 2023 to May 2024