NEW YORK (AP) — Amylin Pharmaceuticals Inc. and Eli Lilly and Co. said Friday that a panel advising the European Medicines Agency recommended a new approval for their diabetes drug Byetta.
The advisory panel recommended that Byetta be approved for use in combination with basal insulin with or without other common diabetes treatments in patients who have not been able to get their blood sugar under control with the other treatments.
If the agency grants approval, that would allow Amylin and Lilly to market the drug to those patients. The EMA is expected to make a decision in two or three months. It does not have to follow the committee's advice, but often does so.
Byetta, or exenatide, is a twice-a-day injection. It was first approved in Europe in 2006. That approval allowed Lilly to market the drug for patients who did not have sufficient blood sugar control on common diabetes medications like metformin.
Amylin and Lilly announced in November that they are ending their collaboration on Byetta and its successor, Bydureon, which is designed to be taken once per week. Amylin is gradually taking over marketing of Byetta outside the U.S.
Amylin is based in San Diego and Eli Lilly in Indianapolis. Shares of Amylin slipped 6 cents to $18.01 in morning trading while Lilly stock picked up 30 cents to $39.02.