MHRA awards first ‘innovation passport’ under new pathway

Regulatory NewsRegulatory News | 26 February 2021 |  By 

MSD's (Merck Sharp & Dohme (UK) Limited) investigational drug belzutifan on Friday became the first drug to be awarded an “innovation passport” under the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) innovative licensing and access pathway (ILAP).
Belzutifan is being developed to treat adults with von Hippel-Lindau disease, a rare cancer-causing genetic disorder, and has been granted orphan designation in the EU and both orphan designation and breakthrough therapy designation by the US Food and Drug Administration (FDA).
ILAP was announced in December and launched at the start of the year to accelerate the development and access to promising medicines and is geared toward medicines that are in the early stages of development. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with MHRA and other stakeholders including the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). (RELATED: MHRA sheds light on pathway to accelerate R&D, Regulatory Focus 24 December 2020).
The innovation passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to create a target development profile (TDP) document to chart out a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include a 150-day accelerated assessment, rolling review and a continuous benefit risk assessment.
“Launched in January this year, the ILAP combines the MHRA’s globally recognised high standards of quality and safety with improved flexibility to reduce the time it takes innovative treatments to be available to [National Health Service] NHS patients,” MRHA said, noting that it has received 10 applications for ILAP so far.
“We are excited to be the first company to receive an innovation passport as part of the new innovative licensing and access pathway (ILAP). We welcome the opportunity to participate in any approach that recognizes the potential value of innovative medicines and seeks to accelerate access for patients who might benefit,” said David Peacock, managing director of MSD (UK) Ltd.


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