Pfizer, Lilly Release Top-Line Results From Phase 3 Study of Tanezumab for Osteoarthritis
April 18 2019 - 4:56PM
Dow Jones News
By Stephen Nakrosis
Pharmaceutical companies Pfizer Inc. (PFE) and Eli Lilly and
Company (LLY) on Thursday released top-line results from a Phase 3
study of tanezumab 2.5 mg and 5 mg.
The study compared long-term joint safety and 16-week efficacy
of tanezumab against nonsteroidal anti-inflammatory drugs in
patients with moderate-to-severe osteoarthritis of the hip or knee,
the companies said.
The companies said the tanezumab 5 mg treatment met two of three
co-primary efficacy endpoints, and demonstrated "a statistically
significant improvement in pain and physical function compared to
NSAIDs at the 16-week analysis." Patients' overall assessment of
their osteoarthritis was not statistically different, the company
said.
Patients who received tanezumab 2.5 mg didn't experience a
statistically significant improvement in pain, physical function or
patients' overall assessment of their osteoarthritis at 16 weeks
compared to NSAIDs, the companies said.
In the safety analysis, there was a higher rate of joint safety
events in the tanezumab arms compared to NSAIDs at 80 weeks, a
difference the companies called "statistically significant."
"We are analyzing these findings in the context of the recent
Phase 3 results as we assess potential next steps for tanezumab,"
said Ken Verburg, tanezumab development team leader, Pfizer Global
Product Development. "We plan to review the totality of data from
our clinical development program for tanezumab with regulatory
authorities."
--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
April 18, 2019 17:41 ET (21:41 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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