US FDA accepts Bydureon app, sets PDUFA
This article was originally published in Scrip
The US FDA said it would make a decision by 28 January 2012 on whether it would permit Amylin and its partner Lilly to market their once-weekly diabetes drug Bydureon (exenatide extended-release for injectable suspension) in the US, after accepting the firm's application and categorizing it as a Class 2 resubmission.
Shares of Amylin rose as high as 5%, or 49 cents, on 11 August on the news, before closing at $10.07, a gain of 38 cents, or 4%, while Lilly's stock jumped $1.66, or 5%, before closing at $35.30, a gain of $1.30, or 3.8%.
The companies have been seeking to market Bydureon, an experimental once-weekly formulation of exenatide, a synthetic drug derived from the saliva of the Gila monster lizard, as a treatment for patients with Type II diabetes. Amylin and Lilly have marketed the twice-daily formulation of exenatide, Byetta, since 2005 in the US.
Both drugs belong to the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.
Bydureon received marketing authorization in the European Union in June.
But the firms have hit obstacles along the way with Bydureon in the US, receiving two complete response letters from the FDA (scripintelligence, 20 October 2010, 15 March 2010).
In the second letter, which came in October 2010, the FDA asked for a thorough QT study – a request that caught the firms and Wall Street by surprise.
The companies in July reported that the FDA-required full QT study confirmed that Bydureon, at and above therapeutic levels, did not prolong corrected QT (QTc) interval in healthy volunteers, nor did not it show dose-dependent increase in QTc interval at higher dose levels – results that paved the way for Bydureon's resubmission (scripintelligence, 11 July 2011, 29 July 2011).
The new drug application for Bydureon was originally submitted in May 2009 based on results of the DURATION program.
Even if Bydureon finally makes it on the US market, it may run into trouble gaining market share. The firms may have made a premarketing misstep by testing Bydureon in a head-to-head trial with Novo Nordisk's FDA-approved GLP-1 agonist Victoza (liraglutide) in an attempt to show which drug was best in reducing A1c in Type II diabetes. But Bydureon failed to even show noninferiority versus Victoza, which analysts said is likely to have significant commercial implications for the drug once it reaches the market (scripintelligence, 4 March 2011).