BRIEF—Geron enters new ILAP in UK for imetelstat

USA-based biotech Geron Corporation says that imetelstat, the company’s first in class telomerase inhibitor, has been granted an Innovation Passport, which is the first prescribed entry point to the Innovative Licensing and Access Pathway (ILAP) launched in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2021, post-Brexit.

The objective of this new licensing and access pathway is to reduce the time to market for innovative medicines.

Key benefits of being within ILAP include a 150-day accelerated assessment and rolling review of a Marketing Authorization Application (MAA), as well as opportunities for frequent interactions with the review staff at the MHRA and its partner agencies, including the National Institute for Health and Care Excellence (NICE), to discuss imetelstat’s development, regulatory plans and reimbursement plans.

Imetelstat is currently being studied in two Phase III clinical trials, IMerge Phase III in lower risk MDS and IMpactMF in refractory myelofibrosis, a chronic blood cancer.

Based upon current planning assumptions, Geron expects top-line results for the IMerge Phase III clinical trial to be available at the beginning of January 2023