FDA Rejects Eli Lilly and Incyte Rheumatoid-Arthritis Drug
April 14 2017 - 12:00PM
Dow Jones News
By Anne Steele
Eli Lilly & Co. and Incyte Corp. on Friday said the U.S.
Food and Drug Administration didn't approve their new drug
application for a rheumatoid arthritis treatment that some analysts
estimate could generate more than $2 billion in annual sales.
Lilly and Incyte said in the FDA's complete response letter for
baricitinib, a once-daily oral medication for the treatment of
moderate-to-severe rheumatoid arthritis, the agency told the
companies to provide more clinical data to determine the most
appropriate doses and clarify safety concerns.
The companies said the timing of resubmitting an application
seeking the drug's approval will be based on further discussions
with U.S. regulators.
"We are disappointed with this action," said Christi Shaw,
president of Lilly Bio-Medicines. "We will continue to work with
the FDA to determine a path forward and ultimately bring
baricitinib to patients in the U.S."
The FDA's decision is a blow to Lilly and Incyte, and it comes a
few months after European Union granted regulatory approval on the
drug, whose brand name is Olumiant.
Olumniant is taken as a pill and is seen as a competitor to
strong-selling injected rheumatoid arthritis drugs such as AbbVie
Inc.'s Humira.
Lilly and Incyte struck a world-wide license and collaboration
agreement for baricitinib in 2009. The agreement called for Lilly
to handle global commercialization of the drug and to pay royalties
on sales once the drug hits the market to Incyte.
The companies submitted the new drug application for baricitinib
to the FDA in January 2016.
In January of this year, the FDA gave a three-month extension to
allow time to review additional data.
On Friday, Lilly reaffirmed its earnings guidance for 2017.
Incyte said it is evaluating the impact of the decision on prior
guidance on milestone payments and full-year
research-and-development expenses. Incyte expects to provide an
update its first-quarter earnings call.
Lilly and Incyte shares, up 14% and 79%, respectively, over the
past 12 months, were inactive on Good Friday.
Write to Anne Steele at Anne.Steele@wsj.com
(END) Dow Jones Newswires
April 14, 2017 11:45 ET (15:45 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
Eli Lilly (NYSE:LLY)
Historical Stock Chart
From Aug 2024 to Sep 2024
Eli Lilly (NYSE:LLY)
Historical Stock Chart
From Sep 2023 to Sep 2024