Pacira BioSciences, Inc., announced that the FDA has awarded their gene therapy product candidate, PCRX-201, the Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of osteoarthritis of the knee. PCRX-201, which is an intra-articular helper-dependent adenovirus gene therapy that codes for the interleukin-1 receptor antagonist, is the first gene therapy product candidate to receive this RMAT designation in the treatment of osteoarthritis.
According to Pacira BioSciences, the RMAT designation comes with numerous benefits such as intensive FDA guidance on efficient drug development, the possibility of prioritized review of the Biologics License Application, and various opportunities to hasten development and review.
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