The first new U.S. FDA-approved therapeutic option for PTSD in more than 20 years will have to wait. A supplemental NDA seeking approval of Rexulti (brexpiprazole) combined with sertraline, filed by one of Japan’s biggest pharmas, Otsuka Pharmaceutical Co. Ltd., received a complete response letter (CRL) from the agency.
In a 10-1 vote, the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said Otsuka Pharmaceutical Co. Ltd.’s studies of its combination post-traumatic stress disorder (PTSD) treatment did not show enough efficacy. Had the adcom felt otherwise, the path may have been smoother for a new treatment in an indication that hasn’t seen regulatory advancement in decades. The committee’s conclusion, however, is not binding on the FDA, which will make its own decision whether to approve.
In a 10-1 vote, the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said Otsuka Pharmaceutical Co. Ltd.’s studies of its combination post-traumatic stress disorder (PTSD) treatment did not show enough efficacy. Had the adcom felt otherwise, the path may have been smoother for a new treatment in an indication that hasn’t seen regulatory advancement in decades. The committee’s conclusion, however, is not binding on the FDA, which will make its own decision whether to approve.
The U.S. FDA is insisting that another study is needed to bolster the sNDA for Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. in treating adults with post-traumatic stress disorder (PTSD). The agency’s Psychopharmacologic Drugs Advisory Committee and the company, one of Japan’s biggest pharmas, will discuss this during July 18’s adcom hearing regarding the efficacy of Rexulti in combination with sertraline.
Japan’s Ministry of Health, Labour and Welfare granted new drug approvals and expanded indications for conditions like cancer, insomnia and Alzheimer’s disease (AD) Sept. 24, including Eli Lilly and Co.’s Kisunla (donanemab) for early symptomatic AD.
Japan’s Ministry of Health, Labour and Welfare granted new drug approvals and expanded indications for conditions like cancer, insomnia and Alzheimer’s disease (AD) Sept. 24, including Eli Lilly and Co.’s Kisunla (donanemab) for early symptomatic AD.
Otsuka Pharmaceutical Co. Ltd.’s AVP-786 missed the primary endpoint for a third time in a phase III trial for agitation associated with dementia due to Alzheimer’s disease (AD). Two previous phase III trials also failed to show statistical significance for AVP-786.
Otsuka Pharmaceutical Co. Ltd.’s AVP-786 missed the primary endpoint for a third time in a phase III trial for agitation associated with dementia due to Alzheimer’s disease (AD). Two previous phase III trials also failed to show statistical significance for AVP-786.
The U.S. FDA’s Office of Prescription Drug Promotion is calling out Otsuka Pharmaceutical Co. Ltd. for making “false or misleading claims and representations about the efficacy of Rexulti” in a television advertisement.
The U.S. FDA’s Office of Prescription Drug Promotion is calling out Otsuka Pharmaceutical Co. Ltd. for making “false or misleading claims and representations about the efficacy of Rexulti” in a television advertisement.
