UK – MHRA awards first ‘innovation passport’ under new pathway

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&DRegulatory Focus 24 December 2020)…