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.
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