Home » Regarding the favorable results of the domestic phase 3 clinical trial of the digital treatment app SDT-001 and the application for domestic manufacturing and sales approval | Shionogi & Co., Ltd.

Regarding the favorable results of the domestic phase 3 clinical trial of the digital treatment app SDT-001 and the application for domestic manufacturing and sales approval | Shionogi & Co., Ltd.

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Shionogi & Co., Ltd. (Headquarters: Chuo-ku, Osaka; Representative Director, Chairman, President and CEO: Isao Teshirogi; hereinafter referred to as “Shionogi & Co.,” or the “Company”) is a subsidiary of Akili, Inc. (Headquarters: Massachusetts, USA; As of February 26th, we have acquired exclusive development and sales rights in Japan and Taiwan from Akili (CEO: Matt Franklin, hereinafter referred to as “Akili”)1. We would like to inform you that we have applied for marketing approval.

SDT-001 is a digital treatment app for pediatric attention-deficit/hyperactivity disorder (ADHD) patients. Akili has previously received U.S. Food and Drug Administration (FDA) approval as the world‘s first digital therapeutic app for improving inattention symptoms in children aged 8 to 17 with ADHD (U.S. Product name: EndeavorRx🄬). In addition, we have obtained the CE mark* in Europe2.

(*CE mark: This mark is a display standard required when shipping and distributing products to the European Economic Area (EEA), which objectively indicates that the safety level of products distributed in the market has been ensured.)

This application for manufacturing and marketing approval in Japan is based on the positive results of the Phase 3 clinical trial (hereinafter referred to as the “Study”) conducted by the Company in Japan. This study was conducted to evaluate the efficacy and safety of SDT-001 in 164 pediatric ADHD patients aged 6 to 17 years who received environmental adjustment and psychosocial treatment that are commonly used in ADHD treatment. This is a test that was conducted.As a result, the SDT-001 group (approximately 25 minutes once a day for 6 weeks) showed that the amount of change from baseline in ADHD-RS-IV inattention score, which is an ADHD severity evaluation scale, was the primary endpoint. [1サイクル] (continued) showed statistically significant improvement (p

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Shionogi & Co., Ltd. has established the SHIONOGI Group Vision to “create the future of healthcare with new platforms,” ​​and aims to transform into a “HaaS company” that provides healthcare services to achieve this vision. While refining our strengths as a drug discovery-oriented pharmaceutical company, we will strengthen our efforts, including collaboration with external partners, and provide a variety of treatment options that go beyond just providing ethical drugs. We will continue to contribute to improving the quality of life of patients and their families.

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