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Pacira BioSciences Says US FDA Granted Knee Osteoarthritis Therapy Candidate RMAT Designation
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Pacira BioSciences Says US FDA Granted Knee Osteoarthritis Therapy Candidate RMAT Designation
Mar 13, 2024 6:26 AM

08:44 AM EDT, 03/13/2024 (MT Newswires) -- Pacira BioSciences ( PCRX ) said Wednesday its gene therapy product candidate, PCRX-201, has been granted Regenerative Medicine Advanced Therapy, or RMAT, designation by the US Food and Drug Administration for the potential treatment of knee osteoarthritis.

The RMAT designation expedites the development and review processes for therapies addressing serious conditions, according to the company.

Pacira said the designation is based on preliminary data from a phase 1 study involving 72 patients, demonstrating safety and efficacy through at least 52 weeks, with further data presentations scheduled for later this year.

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