Novartis have announced that the investigational oral therapy, iptacopan (LNP023), has been awarded an Innovation Passport for the treatment of C3 glomerulopathy (C3G) by the MHRA, NICE, and the SMC. It is currently being investigated in a number of complement-driven renal diseases(CDRDs), alongside one haematological disorder, for patients with high unmet need.
The Innovation Passport is a designation for innovative medicines. It is the entry point to the Innovative Licensing and Access Pathway (ILAP), a new pathway aiming to accelerate the time taken to market, allowing a more rapid patient access to medicines. A single Innovation Passport can cover multiple future indications for the same active substance.
Iptacopan is an investigational, first-in-class, orally administered factor B inhibitor for the alternative pathway of the complement system. It has the potential to become the first targeted therapy to delay progression to dialysis in C3G, and was discovered at the Novartis Institute for BioMedical research. Novartis has a 35-year history in kidney transplantation treatments, however, iptacopan is the first treatment in the nephrology pipeline addressing CDRDs.
C3 glomerulopathy is a group of related conditions that cause the kidneys to malfunction. After kidney transplantation, the risk of recurrence in the transplanted kidney is over 70%, with more than a 50% chance of graft loss.
ILAP was launched in January 2021 as a new pathway aiming to accelerate time to the market, facilitating patient access to medicine. It opens to commercial and non-commercial developers of medicines and provides opportunities for enhanced input from regulatory and other stakeholders. ILAP provides a single integrated platform for collaborative working between the MHRA, healthcare partners including NICE and SMC, and the medicine developer. The Innovation Passport acts as the entry point to the pathway.