The European Medicines Agency has approved an expanded use of Byetta for type 2 diabetes patients, according to Amylin Pharmaceuticals ($AMLN) and Eli Lilly ($LLY), who recently divorced, in part over the drug.
The companies said they received approval for use of Byetta with or without other medications such as metformin and Actos, to help adults who have been unable to get their blood sugars under control.
In clinical trials, patients using Byetta with titrated basal insulin were able to control blood sugars better, without weight gain, than those not using the drug, according to Christian Weyer, M.D., senior vice president of research and development at Amylin Pharmaceuticals.
An advisory panel last month recommended the EMA approve the treatment.
While the two companies jointly developed the drug, in November they dissolved their decade-long alliance. As part of the split, Amylin paid Lilly $250 million for the rights to exanatide products, including Byetta. Lilly still gets a $1.2 billion cut of future sales of Byetta and follow-up products, including the long-acting version known as Bydureon.
Byetta started on an upswing with its debut in 2005, but sales of the drug have declined since then, thanks in part to worries about links to pancreatitis--and, by extension, pancreatic cancer. Byetta also got new competition in the form of newer GLP-1 drugs, including Novo Nordisk's ($NVO) Victoza. Meanwhile, Lilly's bid to gain FDA approval for Bydureon hit repeated setbacks before being approved in January.
It, however, was Lilly's decision to hook up with Boehringer Ingelheim to market its new diabetes drug Tradjenta, which won FDA approval in May, that was the final straw.
- here's the AP story
- get the Amylin statement