EU leapfrogs FDA, approves once-weekly Bydureon for diabetes

While Eli Lilly and Amylin ($AMLN) are battling it out in the courts over Lilly's marketing triangle with Boehringer, the two companies have reason to celebrate together this morning. The EU has approved Bydureon, their once-weekly injectable version of Byetta that they developed with Alkermes.

European regulators declared themselves in favor of the next-gen diabetes treatment, something that the FDA has consistently refused to do as it demanded--twice--additional information of the therapy since it was filed in 2009. For San Diego-based Amylin, it's a particularly important hurdle as the developers work once again to address FDA concerns before the end of this year.

"As the global impact of diabetes continues to expand, so does the need for innovative medicines to help people living with diabetes successfully fit treatment into their lives," said Enrique Conterno, president, Lilly Diabetes. "Bydureon is the first and only once-weekly treatment for type 2 diabetes and has demonstrated powerful efficacy in multiple clinical trials."

For Lilly the approval marks a step forward in its effort to combat the arrival of generic competitors while Amylin has been struggling to turn a profit. Amylin shares were up a little more than six percent this morning.

- see the release
- here's the Dow Jones report
- read the AP story

Suggested Articles

Combining inhibitors of KRAS-G12C, mTOR and IGF1R can significantly shrink lung tumors in mice and human cancer cells, a study found.

X4 Pharmaceuticals has a new R&D chief: Renato Skerlj, who founded the company alongside CEO Paula Ragan and biotech luminary Henri Termeer.

Henlius Biotech missed the $477 million goal it set for its IPO, but still made the top five biopharma IPOs this year with its $410 million listing.