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Europe: UK MHRA awards first ‘innovation passport’ under new pathway

2021/03/01  MHRA

A promising treatment for a cancer-causing rare disease will be the first to pass a significant milestone under a new UK approval process designed to bring medicines more rapidly to patients.

Belzutifan, a treatment developed by MSD (UK) for adults with von Hippel Lindau disease (a rare genetic disorder that causes cancer) has been awarded the first ‘Innovation Passport’ by the Medicines and Healthcare products Regulatory Agency, National Institute for Health and Care Excellence and the Scottish Medicines Consortium (SMC).

This means patients could benefit much sooner from this treatment and it will be accelerated through the approval process; the Innovative Licensing and Access Pathway (ILAP).

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 NHS patients.

Medicines developed through the ILAP will have more focus on patient engagement than ever before. By incorporating patient views, both on the benefits and risks of medicines in the pathway, and on how to improve patient outcomes throughout the product lifecycle, medicines can be developed to meet patient requirements more successfully.

The award of this designation celebrates another first: the successful partnership between the MHRA, NICE and the SMC in making effective joint decisions and awarding Innovation Passports to products that will benefit patients.

The Innovation Passport is the first step in the ILAP and is open to developers of a wide range of medicines, including medicines for rare diseases, repurposed medicines and Advanced Therapy Medicinal Products. Since launch, companies have submitted 10 applications.

Innovation Passport holders, the MHRA and partners will next work together to create a product-specific Target Development Profile (TDP) for the new medicine. The TDP will define key regulatory and development features, identify potential pitfalls, offer access to specialist toolkits and create a roadmap for delivering early patient access.

The TDP will also outline how the Innovation Passport holder can work together with other UK stakeholders to achieve coordinated, efficient evidence generation and evaluation, and address considerations regarding patient access.

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