A promising treatment for a cancer-causing rare disease is set to become the first innovative medicine in the UK to be awarded an ‘Innovation Passport’ under a new national approval process.
The Innovative Licensing and Access Pathway (ILAP) has been established to reduce the time to market for innovative treatments, supporting quicker development and access to cutting-edge medicines.
Belzutifan has become the first to be awarded approval under the ILAP process; a treatment developed for adults with von Hippel Lindau (a rare genetic disorder that causes cancer).
Innovation Passports, as the ILAP approval has been colloquially called, are approved by the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC).
The approval of belzutifan through this process means patients could benefit much sooner from the potentially transformative treatment, and will see it accelerated through the approval process.
The ILAP was launched back in January, but this is the first award given under it.
As part of the ILAP approval process, potential innovative medicines must still work to the MHRA’s globally-recognised high standards of quality and safety, but will benefit from improved flexibility to reduce the time it takes for these treatments to be available to NHS patients.
Dr June Raine CBE, Chief Executive of the MHRA, said: “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.
“Patients are our top priority and are involved at every stage of this process.
“Together, we look forward to bringing more Innovation Passport holders on board to deliver earlier access to these products, better outcomes for patients and to continue our transformation.”
Chief Executive of the ABPI, Richard Torbett, said: “It’s great to see the ILAP moving forward quickly with the award of the first innovation passport.
“Now the MHRA is a sovereign medicines regulator, this scheme is a really positive sign that the UK is serious about accelerating the approval of innovative new medicines, which is a win for patients, the NHS and industry.
“We look forward to seeing medicines coming through this scheme and getting to the people who need them as quickly as possible.”
