Pacira's PCRX-201 Gets FDA RMAT Designation in Knee Osteoarthritis
By Colin Kellaher
Pacira BioSciences has won a key U.S. Food and Drug Administration designation for its PCRX-201 gene-therapy product candidate for the treatment of osteoarthritis of the knee.
Pacira on Wednesday said the FDA granted regenerative-medicine-advanced-therapy, or RMAT, designation to PCRX-201, marking the agency's first-ever RMAT designation for a gene-therapy product candidate in osteoarthritis.
The FDA's RMAT designation offers eligibility for expedited development and regulatory review of product candidates, including earlier and more frequent consultation with the agency, and the potential for accelerated approval.
Tampa, Fla., pain-management company Pacira said the PCRX-201 designation is supported by encouraging preliminary data from a 72-patient phase 1 study.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 13, 2024 07:56 ET (11:56 GMT)
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