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Emyria encouraged by US FDA’s position on real-world data on CBD regulation

Published: 10:27 27 Jan 2021 AEDT

Emyria Ltd - Emyria encouraged by US FDA’s position on real-world data on CBD regulation
Emyria has been collecting high quality RWD with patients seen through its clinical subsidiary - Emerald Clinics

Emyria Ltd (ASX:EMD) is encouraged by a recent perspective shared by the leadership of the US Food and Drug Administration (FDA) highlighting the potential role of real-world data (RWD) to improve the understanding of the safety and uses of cannabidiol (CBD). 

The data-backed drug development company believes the increasing interest and support for high-quality RWE from the FDA, particularly in the field of cannabinoid medicines, bodes well for its strategy to use its proprietary data platform and unique RWE assets to inform and support multiple drug registration programs targeting unmet needs.

FDA’s strong support

Emyria managing director Dr Michael Winlo said: “We’re encouraged, but not surprised, by the FDA leadership’s strong support for carefully collected RWD to help improve our understanding of cannabinoid medicines specifically.

“Dr Amy Abernethy has been a pioneer in RWE as a key leader at Flatiron Health prior to joining the FDA.

“This recent FDA leadership perspective highlights the value the FDA places on high-quality RWD but also reinforces their strict standards for high-quality clinical evidence to support drug registration.

Launch own drug development and registration programs

“Since our founding, Emyria has been using the unique regulatory circumstances in Australia to gather what we now believe to be the largest and highest quality RWD set on pharmaceutical-grade cannabinoid medicines in the world.

“We are now using this data to launch our own drug development and registration programs targeting major unmet needs and intend to use our RWD and supporting trial data to seek registration with the TGA and then other global regulators, like the FDA.”

FDA’s position

In an article titled ‘Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products’, Dr Stephen Hahn, immediate past Commissioner of Food and Drugs and Dr Amy Abernethy, Principal Deputy Commissioner state: “We think that real-world data (RWD) on CBD use and safety has a crucial role alongside data from other types of studies to fill in the current gaps in our understanding.”

“... we strongly believe that RWD, when collected and analyzed using rigorous methods, can be important for moving the science forward—including by aiding hypothesis generation and by refining the design of follow-up studies.

“For example, RWD may identify new potential adverse events or subpopulations of CBD users that should be the focus of follow-up studies.”

According to research conducted by US-based RWE company, Aetion, 75% of recent drug registration applications to the FDA now contain RWE as part of the evidence submitted, up from 45% of applications in 2019 from a year ago.

EMD-003

Emyria has been collecting high-quality RWD with patients seen through its clinical subsidiary - Emerald Clinics, which now covers over 3,000 patients and is constantly growing in-patient numbers and longitudinally.

Emyria’s first program, EMD-003, will seek registration of a specific cannabinoid treatment for a defined group of patients with symptoms of psychological distress and the symptoms of anxiety, depression and stress.

Pivotal registration studies are being designed for EMD-003 from Emyria RWD outcomes.

EMD-003 is seeking registration with the Therapeutic Goods Administration (TGA) and, if successful, will pursue registration with other global regulators such as the FDA.

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