FDA slaps CRL on Otsuka and Lundbeck’s Rexulti sNDA
Danish CNS specialist Lundbeck (LUND: CO) and the US subsidiary of Japan’s Otsuka (TYO: 4578) announced that the latter has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the supplemental New Drug Application (sNDA) for use of Rexulti (brexpiprazole) in combination with sertraline as a treatment of adults with post-traumatic stress disorder (PTSD).
The CRL states that the FDA has completed its review but cannot approve the application in the current form, as the application does not provide substantial evidence of effectiveness to support the approval.
The sNDA for brexpiprazole in combination with sertraline for the treatment of adults with PTSD was accepted for review by the FDA in June 2024 and was based on data from three randomized clinical trials that evaluated the safety and efficacy of brexpiprazole in combination with sertraline in adult patients with PTSD.
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