Eli Lilly & Co. said an experimental, once-weekly drug for
Type 2 diabetes was comparable to Novo Nordisk A/S's once-daily
Victoza in reducing a measure of blood sugar in a patient study, a
finding Lilly hopes will give it a competitive advantage if its
drug reaches the market.
Lilly said its long-acting drug, dulaglutide, wasn't superior to
Victoza, which had 2013 sales of about $2.1 billion. Lilly
disclosed an abbreviated summary of the trial's results in a news
release Tuesday, and plans to present full data at a scientific
meeting later in the year.
Lilly applied for U.S. and European regulatory approval of
dulaglutide last year based on results of prior clinical trials,
and expects regulatory decisions later this year. It is one of
three Lilly diabetes drugs under regulatory review, part of Lilly's
strategy to regain lost ground in the competitive diabetes drug
market. ISI Group estimates dulaglutide could generate about $2
billion in peak annual sales if it is cleared by regulators.
Dulaglutide belongs to a class of drugs known as glucagon-like
peptide-1, or GLP-1, receptor agonists. They're designed to help
increase insulin production and regulate blood-sugar levels in
people with Type 2 diabetes, the most common form of diabetes.
Other drugs in the class include AstraZeneca PLC's Byetta and
Bydureon; Victoza is the segment leader.
The latest trial of dulaglutide, titled "Award 6," gave nearly
600 patients either dulaglutide or Victoza, and tracked their
hemoglobin A1c, or HbA1c, a measure of blood-sugar control, for 26
weeks. The Lilly-funded study's primary goal was to show that
dulaglutide was "non-inferior" to Victoza, or within 0.4% in
average reduction of HbA1c.
Sherry Martin, a Lilly senior medical director, said in an
interview dulaglutide wasn't superior to Victoza in average HbA1c
reduction. But she said the study marked the first time that
another GLP-1 had been shown to be noninferior to Victoza.
Adverse events were comparable between dulaglutide and Victoza,
with the most frequently reported events being
gastrointestinal-related, Lilly said.
Novo Nordisk said Victoza has "a proven record" of effectively
helping patients with Type 2 diabetes control their blood sugar
daily since the drug was approved by the U.S. Food and Drug
Administration in 2010. The company said it planned review the full
data set from the Lilly study before assessing its meaning any
further.
Write to Peter Loftus at peter.loftus@wsj.com
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