Awakn Life Sciences Corp. announced the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted Awakn an Innovation Passport as part of the Innovative Licensing and Access Pathway (ILAP) for its proprietary ketamine-assisted therapy for the treatment of Severe Alcohol Use Disorder. Alcohol use disorders affect 285 million people globally, of these circa. 25% or 70m people suffer with Severe Alcohol Use Disorder. ILAP aims to accelerate time to market, facilitating patient access. Similar to the FDA's fast-track program in the United States, the U.K.'s MHRA Innovation Passport provides Awakn with access to specialist advice from the MHRA and its partners, including the National Institute of Health and Care Excellence (NICE). Throughout the therapeutic development process this has the potential to enable a more efficient, and ultimately a faster route to marketing authorization. The ILAP provides a single integrated platform for sustained collaborative working among the MHRA,
several key bodies and the therapeutics developer, allowing for earlier engagement, enhanced coordination and monitoring of important product development activities culminating in market authorisation. This also has the potential to allow the National Health Service (NHS) to adopt potential treatments faster and ultimately enable quicker patient access to these potential medicines. Under the ILAP, Awakn will have access to a toolkit to support all stages of the design, development, and approvals process, as well as identify key areas for future agency engagement.