Once-Weekly Bydureon Wins Long-Awaited FDA Approval

By Jennifer Boggs

Managing Editor

Amylin Pharmaceuticals Inc. can (finally) put another check in the win column, with the FDA’s approval of Bydureon, a once-weekly version of Type II diabetes drug exenatide, a move that puts the San Diego-based biotech on solid footing for a lucrative ex-U.S. partnering deal – even a potential buyout isn’t out of the question.

Bydureon watchers were pretty confident going in to the Jan. 27 PDUFA date – Deutsche Bank analyst Robyn Karnauskas viewed approval as “highly likely” – but some doubts lingered, particularly given the agency’s previous actions on the GLP-1 agonist.

In March 2010, Amylin and partners Eli Lilly and Co. and Alkermes Inc. got a complete response letter citing outstanding issues regarding manufacturing and the drug’s risk evaluation and mitigation strategy. Those were quickly resolved, but the FDA stunned the companies seven months later with a second complete response letter requesting a thorough QTc study to evaluate the risk of higher-than-therapeutic doses of Bydureon on the cardiovascular safety profile. (See BioWorld Today, March 16, 2010, and Oct. 21, 2010.)

The new drug application was resubmitted after the required study, completed early last year, showed that the drug did not prolong the corrected QTc interval in healthy individuals and showed no relationship between QTc interval and plasma exenatide concentrations.

But the delay did have its consequences. During the lag time, Indianapolis-based Lilly inked a deal with Boehringer Ingelheim GmbH on diabetes drug Tradjenta (linagliptin), which it wished to market with the same sales force that promoted the Amylin-partnered Byetta (once-daily exenatide). Amylin attempted to block Lilly from selling both drugs with the same team, even taking its decade-long partner to court. (See BioWorld Today, May 17, 2011.)

At the same time, some investors worried about Lilly’s commitment to Bydureon in the event it gained approval of its own GLP-1 agonist, LY2189265, which analysts predicted could happen as early as 2013.

All of that led to Lilly agreeing late last year to exit the partnership. Under the terms, Lilly handed over all U.S. sales of the exenatide franchise to Amylin at the end of 2011. Outside the U.S., the big pharma will continue selling the drug for a transition period – to expire Dec. 31, 2013 – during which Amylin will work to secure a new deal. (See BioWorld Today, Nov. 9, 2011.)