Novartis Pharmaceuticals UK’s investigational oral therapy, iptacopan (LNP023), has been awarded an Innovation Passport for the treatment of C3 glomerulopathy (C3G) by the Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC).1
The Innovation Passport is the entry point to the Innovative Licensing and Access Pathway (ILAP), a new pathway aiming to accelerate the time to market, facilitating patient access to medicines. A single Innovation Passport can cover multiple future indications for the same active substance.2 Therefore, other conditions may also be considered in subsequent steps of ILAP. Iptacopan is currently in development for a number of complement-driven renal diseases (CDRDs) where significant unmet needs exist, including C3G, IgA nephropathy, atypical haemolytic uraemic syndrome, and membranous nephropathy, as well as the rare blood disorder paroxysmal nocturnal haemoglobinuria.
“Ensuring our medicines reach patients who need them most is our key priority. We are proud to be developing a medicine which has been awarded an Innovation Passport under the new Innovative Licensing and Access Pathway,” said Chinmay Bhatt, Managing Director UK, Ireland & Nordics for Novartis Pharmaceuticals. “We are excited about engaging with UK healthcare system stakeholders through this new pathway to explore the opportunities for bringing this developmental medicine to patients as quickly as possible.”
- Iptacopan – Approval Letter Innovative Licensing and Access Pathway
- Innovative Licensing and Access Pathway. Guidance. Available at: https://www.gov.uk/guidance/innovative-licensing-and-access-pathway. Accessed October 2021