Iptacopan has been awarded the Innovation Passport for the treatment of C3 glomerulopathy (C3G) and is currently being investigated in a number of complement-driven renal diseases and one haematological disorder for patients with high unmet need1
The Innovation Passport is a designation for innovative medicines. It is the entry point to the Innovative Licensing and Access Pathway (ILAP), which aims to support the development of these medicines and bring them to patients more rapidly2
Novartis is committed to ensuring their medicines reach patients who need them most and is excited to explore the opportunities through this new pathway to bring iptacopan to eligible patients
London, UK, 28 October, 2021 — Novartis is pleased to announce the 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.”
About iptacopan (LNP023) Iptacopan is an investigational, first-in-class, orally administered factor B inhibitor of the alternative pathway of the complement system.3,4,5 It has the potential to become the first targeted therapy to delay progression to dialysis in C3G and was discovered at the Novartis Institutes for BioMedical Research.
While Novartis has a 35-year history in kidney transplantation treatments, iptacopan is the first treatment in the nephrology pipeline addressing CDRDs. Our aim is to transform treatment by targeting one of the key drivers of these rare and often progressive diseases3 and, in doing so, potentially extend dialysis-free life for people with CDRDs.
About Innovative Licensing and Access Pathway (ILAP) ILAP was launched in January 2021. It is a new pathway aiming to accelerate the time to market and facilitate patient access to medicines. It provides a single integrated platform for collaborative working between the MHRA, healthcare partners including NICE and SMC, and the medicine developer. The ILAP is open to commercial and non-commercial developers of medicines and provides opportunities for enhanced input from regulatory and other stakeholders. The Innovation Passport acts as the entry point to the pathway.
About Novartis Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we strive to use innovative science and digital technologies to create treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach more than 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world.
In the UK, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis. Since 2014, Novartis has invested over £200 million in R&D and is a leading sponsor of clinical trials in the UK. For more information, please visit www.novartis.co.uk.