Following consideration by MHRA, NICE, and SMC, the Innovative Licensing and Access Pathway Steering Group has informed AKL that the innovative medicine designation, the Innovation Passport, has been awarded for APPA in the treatment of osteoarthritis.
The Innovation Passport is the entry point to the Innovative Licensing and Access Pathway (ILAP) designed to accelerate the development and access to promising medicines in the UK, thereby facilitating and improving patient access to new medicines. To qualify for the pathway, new medicines must offer significant benefits to patients with a life-threatening or seriously debilitating condition, or meet a significant patient or public health need.
The MHRA launched the ILAP program in January 2021 to support innovative approaches to the safe, timely and efficient development of promising medicines in the UK. ILAP is a key part of the UK’s post-Brexit regulatory framework for new medicines and is similar to the EU and FDA fast track process. More information about the ILAP program can be found here.
The Innovation Passport will allow AKL to work with the MHRA and health technology assessment (HRA) agencies on a Target Development Profile for APPA, that will set out an accelerated roadmap of future development and regulatory milestones.
APPA is currently a Phase II clinical asset.