Product News and Recalls

European agency approves controversial diabetes drug

A report on the blog FiercePharma says the European Medicines Agency – which evaluates medical products for the European Union – has approved an expanded use of the drug Byetta for type 2 diabetes patients.

Byetta is now approved for use with or without other medications such as metformin and Actos, to help adults who have been unable to get their blood sugars under control.

The decision was expected after an advisory panel recommended the EMA grant the approval.

The report says Byetta, developed jointly by Amylin Pharmaceuticals and Eli Lilly, was an initial success following its 2005 debut. But sales dropped off after subsequent studies linking Byetta and another diabetes drug, Januvia, to pancreatitis and pancreatic cancer. A study also linked Byetta to an increased risk of thyroid cancer.

The approval of newer diabetes medications, including Victoza from Novo Nordisk, also cut into Byetta’s sales.

Amylin Pharmaceuticals and Eli Lilly dissolved their alliance last year, the report says. Amylin paid Lilly $250 million for the rights to the class of products that includes Byetta, with Lilly getting a $1.2 billion cut of future sales of Byetta and follow-up products such as the long-acting version called Bydureon.

You should consult with a doctor if you have any ongoing symptoms or health concerns, and before making any changes in medication. You should also consult with a Lopez McHugh attorney if you or a loved one was diagnosed with pancreatic cancer after taking Januvia or Byetta.

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