Two or three months for a pop or drop.
European committee endorses Bydureon for approval
European medical committee endorses potential diabetes treatment Bydureon for approval
On Friday April 15, 2011, 3:24 pm EDT
INDIANAPOLIS (AP) -- Drugmakers Eli Lilly and Co. and Amylin Pharmaceuticals Inc. said Friday that a European committee has endorsed their potential diabetes treatment Bydureon, a key step toward possible approval in the European Union.
Bydureon is a once-weekly, injectable version of the type 2 diabetes treatment Byetta, which was developed by San Diego-based Amylin and Indianapolis-based Lilly.
The companies said the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval. The European Commission, which approves medicines for the European Union, usually makes a decision on these recommendations in two or three months.
Alkermes Inc. of Waltham, Mass., also is involved in developing the longer-lasting versions of Byetta, which is injected twice a day.
Shares of Amylin jumped 17 percent, or $1.94, to $13.20 in Friday afternoon trading, while Alkermes climbed 4.3 percent, or 57 cents, to $13.98, and Lilly rose 23 cents to $35.98.
Analysts see Bydureon as an important potential revenue source for Amylin, which has one other drug on the market aside from Byetta. Lilly, meanwhile, has a portfolio that includes eight drugs that passed $1 billion in sales last year.
The companies said last month that Bydureon proved inferior to a daily version of Novo Nordisk's Victoza, according to initial results from a late-stage study comparing the drugs.
In the United States, the Food and Drug Administration declined to approve Bydureon in October and asked the companies for more data about the drug. The companies plan to respond in the second half of this year.
The companies also are developing a monthly version of Bydureon, and they said in March that it did well in a small, mid-stage study measuring effectiveness, safety and tolerability.
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