Pfizer, Lilly Release Top-Line Results From Phase 3 Study of Tanezumab for Osteoarthritis

   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 [e-mail]

(END) Dow Jones Newswires

April 18, 2019 17:41 ET (21:41 GMT)

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