FDA OK on Amylin Drug Safety: BioBuzz
SAN DIEGO (
) --U.S. regulators delayed the approval of a new long-acting diabetes drug from
Amylin Pharmaceuticals
(AMLN)
and
Eli Lilly
(LLY) - Get Report
to finalize the medicine's label and to clarify manufacturing.
While the U.S. Food and Drug Administration failed to approve Bydureon (previously known as exenatide once-weekly) Friday, the agency did not ask Amylin and Lilly to conduct new clinical trials or to submit additional safety data.
Amylin said it would work quickly to submit a response to the FDA's questions in the next few weeks. The company added that concerns about its Ohio manufacturing facility raised by FDA during a December inspection have already been corrected.
"This is a significant step forward in our ability to bring this important therapy to patients," said Dr. Orville Kolterman, Amylin's senior vice president of research and development, in a statement.
Bydureon is a once-weekly formulation of the twice-daily injectable drug Byetta, currently marketed by Amylin and Lilly. Byetta sales total around $700 million, but the more convenient Bydureon is expected to bring in well over $1 billion in revenue and be a major growth driver for the companies, according to analysts.
The drug-delivery technology that enables Bydureon to be dosed so infrequently comes from
Alkermes
(ALKS) - Get Report
, which will receive royalties on sales of the drug when approved.
Bydureon and
Novo Nordisk's
(NVO) - Get Report
recently approved Victoza belong to the GLP-1 class of injectable diabetes drugs intended to control blood sugar in Type 2 diabetes medicines. Victoza requires a once-daily injection.
Amylin shares closed Friday at $20.26; Alkermes shares closed at $12.21.
-- Reported by Adam Feuerstein in Boston.
Follow Adam Feuerstein on
.
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
to send him an email.