Though Amylin managed to resubmit the NDA for its eagerly awaited type 2 diabetes treatment Bydureon just a month after the "complete response" letter from FDA, the firm - and partners Eli Lilly and Alkermes - will have to wait until October for a final decision from FDA.

As expected, the long-acting formulation of Byetta (exenatide) is due for a new user fee date in October. The glucagon-like peptide-1 agonist has been assigned a Class II resubmission, which entails a six-month review, according to a joint statement from the partners on May 6. A new action date has been set for Oct. 22, 2010.

The companies resubmitted the Bydureon NDA in April, in response to FDA's "complete response" letter from March (Also see "FDA's "Complete Response" Letter For Byetta LAR Isn't Too Onerous, Amylin Says" - Pink Sheet, 15 March, 2010.).

The issues raised in the "complete response" letter were fairly straightforward, but as it did involve a Risk Evaluation and Mitigation Strategy, it was expected that the review clock would be six months as opposed to a two month Class I resubmission.

"Today's development is in line with our expectations (as an REMS is still being negotiated), but given that some investors were holding out hope for a two-month Class 1 review, the news could be met with modest disappointment in the market." J.P. Morgan analyst Cory Kasimov commented in a May 6 note.

Meanwhile, other drugs in the same class are gaining ground.

Novo Nordisk has been successfully taking share from twice-daily Byetta with its once-daily GLP-1 agonist Victoza . In its first 10 weeks of launch, liraglutide reached a 10 percent share (scripts) of the GLP-1 market, the company recently reported (Also see "Novo Nordisk's GLP-1 Victoza Off To A Good Start" - Pink Sheet, 27 April, 2010.). With a contribution of about $66 million, Victoza helped drive the company's quarterly sales by 9 percent from the same time last year, to roughly $2.3 billion.

Novo Nordisk also is gearing up to start the cardiovascular outcomes study for liraglutide, to fulfill FDA's requirement that cardiovascular risk be assessed for type 2 diabetes drugs (and a post-marketing commitment for the Victoza approval). Beginning in the fall, the LEADER trial will enroll up to 9,000 patients who will be treated for five years with standard of care plus Victoza versus standard of care alone.

But the setback in the Bydureon schedule also means that another GLP-1 contender will have narrowed the margin in its market lead. Roche/Ipsen plan to file its GLP-1 analog taspoglutide in 2011 ([A#14160318006]). Taspoglutide represents a wildcard for Bydureon investors, Kasimov noted, ahead of the release of Phase III results at the American Diabetes Association meeting in June.

"Based primarily on our physician discussions and extensive survey work in the space, we still believe Bydureon is the long-acting GLP-1 agonist to beat. However, we also suspect investor apprehension may increase as we approach the release of detailed results," Kasimov wrote.

- Emily Hayes ( e.hayes@elsevier.com )

GLP-1 Showdown Set For Fall: Bydureon Gets New October Review Deadline

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