IRDiRC member InnoSkel, a pioneering biotechnology company developing transformative therapies for the unmet needs of individuals with rare bone disorders, announced on December 16, 2021 that it has been awarded an Innovation Passport under the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) Innovative Licensing and Access Pathway (ILAP), to pursue accelerated patient access for its first-in-class treatment for spondyloepiphyseal dysplasia congenita (SEDc), a type II collagen disorder.
The MHRA’s ILAP was launched at the start of 2021 and aims to accelerate the time to market, facilitating safe, early and financially sustainable patient access to medicines. The pathway features enhanced input and interactions with the MHRA and other stakeholders including the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC). The decision to award the Innovation Passport to InnoSkel’s lead gene therapy program, INS-101, was made by the ILAP Steering Group, which is comprised of representatives from MHRA, NICE, and SMC.
To receive an Innovation Passport, INS-101 met the following criteria:
- the condition is life-threatening or seriously debilitating;
- the program is intended for a rare disease or special population; and
- the medicine has the potential to offer benefits to patients.