Amylin, Alkermes say diabetes drug safe for heart
Amylin and partners say weekly diabetes injection does not affect heart activity
On Thursday July 7, 2011, 6:55 pm EDT
WASHINGTON (AP) -- Shares of Amylin and Alkermes Inc. climbed Thursday after the companies said their once-per-week diabetes medication appears safe for the heart, addressing concerns that delayed its federal review last year.
The drug, Bydureon, is designed to be a next-generation version of the twice-daily injection Byetta, which is currently marketed by Amylin and Eli Lilly & Co. Inc. Alkermes, based in Waltham, Mass., created the technology that gradually releases the drug over the course of a week.
The Food and Drug Administration declined approval for Bydureon in October, saying more information on its effect on the heart was needed.
The companies said a 75-patient study of Bydureon showed it did not interfere with the electrical activity of the heart even at high doses, a key safety measure in drug trials.
"We are confident in these results and will continue to work toward making Bydureon available to patients in the U.S. as soon as possible," said Christian Weyer, senior vice president at Amylin Pharmaceuticals.
Bydureon is part of a new wave of diabetes treatments designed to treat the rising epidemic of the disease in the U.S. However, the FDA has raised safety standards for such treatments after GlaxoSmithKline's blockbuster diabetes pill Avandia was linked to heart attack risks.
New drugs that have already reached the market include Merck & Co.'s Januvia and Bristol-Myers Squibb Co. and AstraZeneca's Onglyza. Those drugs are technically in a different class from Bydureon but work with the same goal of controlling blood sugar levels.
Regulators for the European Union approved Bydureon last month.
Lilly is based in Indianapolis, and Amylin is headquartered in San Diego.
Shares of Amylin Pharmaceuticals Inc. rose $1.44, or 10.5 percent, to $15.15 in afterhours trading. Alkermes tacked on $1.17, or 6 percent, to $20.40. Lilly was unchanged.
surf's up......crikey
