On January 23rd (US time), Handok’s affiliate Rezolute announced that its developmental drug for congenital hyperinsulinism, RZ358, received the Innovation Passport from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The Innovation Passport was granted based on the unmet medical needs for congenital hyperinsulinism and the significant improvement in hypoglycemia cases demonstrated in the Phase 2 RIZE clinical trial of RZ358.

The UK’s Innovation Passport is part of the Innovative Licensing and Access Pathway (ILAP) and is designed to accelerate the launch of products and enhance patient access to drugs. The Innovation Passport is the first step in the ILAP process. Receiving the Innovation Passport enables more active collaboration with partner institutions, including the MHRA, the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC).