The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Awakn Life Sciences an Innovation Passport for its proprietary ketamine-assisted therapy for the treatment of Severe Alcohol Use Disorder.
The passport has been granted as part of the UK’s Innovative Licensing and Access Pathway (ILAP). The ILAP aims to accelerate time to market and provide access to specialist advice from the MHRA and its partners, including the National Institute of Health and Care Excellence (NICE).
It also 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.
Awakn CEO, Anthony Tennyson, commented: “Ensuring our therapeutics reach people who need them most is our key priority as a company.
“Having an innovation passport gives us the opportunity working with the regulators to find the most efficient pathway to marketing authorisation and ultimately and most importantly to those people who desperately need it.
“We are very grateful to the MHRA and its partners for identifying the vast potential in our treatment.”
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.
Awakn’s Head of Ketamine-Assisted Therapy, Professor Celia Morgan, added: “The award of Innovation Passport status validates development of our highly innovative therapeutic approach of using ketamine-assisted psychotherapy to treat severe alcohol use disorder and our desire to bring this therapeutic approach to patients as rapidly as possible.
“This will enable us to build optimally on the excellent phase II proof of concept study as we work in partnership towards marketing authorisation.
“We look forward to working closely with the MHRA, NICE and partners to accelerate our planned phase 3 clinical trial, to be undertaken in collaboration with the NIHR, MRC, NHS, and Exeter University.”
