Belzutifan Becomes First Medicine Approved Via UK’S New ILAP Pathway

Date: March 2, 2021 | Country: UNITED KINGDOM | Region: EU27 + UKEUROPE | Type: Regulation | Keywords: #belzutifan #brexit #eu #hippellindau #mhra #msd #uk

PRICENTRIC BRIEF:

  • MSD’s belzutifan (formerly MK-6482) has become the first treatment to be awarded an “Innovation Passport” through the Medicines and Healthcare products Regulatory Agency’s (MHRA) new Innovative Licensing and Access Pathway (ILAP)
  • The therapy is being evaluated for adults with von Hippel Lindau disease, and because of the new pathway patients could gain access to the treatment sooner than through regular frameworks
  • In January 2021, the MHRA announced the implementation of the new pathway for innovative medicines, combining the MHRA’s independence and high standards of quality, safety, and efficacy, with “improved efficiency and flexibility,” readying the organization for a “new era in medicines approvals in the UK”

 

THE DETAILS

LONDON, United Kingdom – MSD’s belzutifan (formerly MK-6482) has become the first treatment to be awarded an “Innovation Passport” through the Medicines and Healthcare products Regulatory Agency’s (MHRA) new Innovative Licensing and Access Pathway (ILAP).

The therapy is being evaluated for patients with von Hippel Lindau disease, and because of the new pathway patients could gain access to the treatment sooner than through regular frameworks.

Dr June Raine CBE, Chief Executive of the MHRA, noted: “We’re transforming the MHRA to make the regulator an enabler of innovation. I’m very pleased to announce the first Innovation Passport designation demonstrating that this process is well underway.

Our Innovative Licensing and Access Pathway is already working to deliver new and innovative treatments to patients through strong and effective partnerships.”

ILAP

When leaving the European Union and establishing itself as the UK’s standalone drug regulator, the MHRA announced the implementation of the new pathway for innovative medicines, combining its own independence and high standards of quality, safety, and efficacy, with “improved efficiency and flexibility,” readying the organization for a “new era in medicines approvals in the UK.”

The project means that companies can now submit medicines since January 1st, following close collaboration between NICE, drug regulators, the NHS, and equivalent organizations in Scotland.

In recently-published guidance, the MHRA confirmed that the ILAP enables multiple entry points depending on:

  • the stage of development of the product
  • the data available
  • the ambition of the applicant to engage with UK stakeholders
  • the applicant’s appetite for new innovative ways of working

It is worth noting that the scheme does not directly replace the Early Access to Medicines Scheme (EAMS), which will remain a part of play as it already is.

The new system includes the novel “Innovation Passport,” which is a new medicine designation, acting as the gateway to enter into the pathway and will be awarded to innovative products – such as belzutifan – submitted to the ILAP. This includes the likes of Advanced Therapy Medicinal Products (ATMPs), medicines for rare diseases, and repurposed medicines.”

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