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Activity Number: 403 - SPAAC Poster Competition
Type: Topic Contributed
Date/Time: Tuesday, July 30, 2019 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #304651
Title: RWE for Lorazepam IV Regulatory Approval in Japan
Author(s): Richard B. Chambers and Kelly H Zou* and Yoshiomi Nakazuru and Shintaro Hiro and Michinori Terada and Alexa Parliyan and Ahmed Shelbaya and Patricia Schepman
Companies: Pfizer Inc and Pfizer Inc and Pfizer R&D Japan and Pfizer R&D Japan and Pfizer R&D Japan and Pfizer Inc and Pfizer Inc and Pfizer Inc
Keywords: Real World Evidence; Real World Data; Regulatory Science; Lorazepam; Diazepam

Real world evidence (RWE) was used to provide reference information for lorazepam IV in status epilepticus among infants aged 3+ months in Japan. A small clinical trial was conducted with lorazepam IV in Japan for the indication of status epilepticus and the new drug application was approved in 2018. The primary endpoint did not meet the pre-specified target efficacy criteria while the key secondary endpoint supported efficacy. The target number of nursing infants (3 months to < 1 year) was 3+ subjects, and only 1 patient was enrolled. Pharmaceuticals and Medical Devices Agency (PMDA), the regulatory agency in Japan, inquired the usage of lorazepam IV and diazepam IV outside of Japan to treat pediatric patients aged 3+ months using real world data (RWD). We demonstrated usage of lorazepam IV for pediatric patients compared to diazepam IV among nursing infants outside of Japan. This was a successful example of the use of RWE to support regulatory decision making, and various assets may leverage this experience in future regulatory interactions.

Authors who are presenting talks have a * after their name.

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