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FDA needs more time to
review AbbVie, Neurocrine's uterine pain drug
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[April 11, 2018] (Reuters)
- AbbVie Inc and Neurocrine Biosciences Inc
said on Tuesday the U.S. Food and Drug Administration notified the
companies that it requires more time to review the marketing application
for their uterine pain drug.
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 The agency requested more time to review additional information
regarding the results of liver function tests provided by AbbVie in
connection with the application for Elagolix in
endometriosis-associated pain, the companies said.
The request comes a month after it extended the time to review rival
Allergan Plc's uterine fibroids drug Esmya.
Four reports of serious liver injury in patients treated with the
drug caused European regulators to open a review into Allergan's
rival drug in December.
"This is just the FDA being consistent in their request for similar
indications," said Baird analyst Brian Skorney, adding that he did
not think the issue was specific to Elagolix.
FDA is now expected to make its decision on AbbVie's drug in the
third quarter of 2018, three months later than initially expected.
Endometriosis occurs when the lining of the uterus grows outside of
the womb, leading to chronic pelvic pain. It is the leading cause of
infertility.
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Neurocrine and AbbVie are also testing Elagolix for the treatment of
uterine fibroids in late-stage clinical studies.
AbbVie said the marketing application for Elagolix was based on data
from the largest prospective randomized clinical trials conducted to
date for endometriosis, and that it remained confident in its
application for the drug.
In June 2010, Neurocrine and AbbVie entered into an exclusive
worldwide collaboration to develop and commercialize Elagolix.
Neurocrine's shares were down 4.3 percent at $75.79 in morning
trading.
(Reporting by Tamara Mathias and Manas Mishra in Bengaluru; Editing
by Bernard Orr)
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