Chiesi wins Innovation Passport from UK MHRA for its Fabry treatment

26 November 2021

The UK subsidiary of Italian family-owned Chiesi Farmaceutici announced yesterday that pegunigalsidase alfa (PRX-102) was awarded Innovation Passport status by the UK Medicines and Healthcare products Regulatory Agency (MHRA) on August 25, 2021.

The Innovation Passport is the mandated entry point to the MHRA’s new Innovative Licensing and Access Pathway (ILAP), which aims to accelerate the time to market, facilitating patient access to medicines. The pathway allows early interactions with the MHRA and other stakeholders, including the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC).

To receive an Innovation Passport, PRX-102 met the following criteria: (1) the condition is life-threatening or seriously debilitating; (2) the program is intended for a rare disease or special population; and (3) the medicine has the potential to offer benefits to patients. The Innovation Passport designation is the first step in the ILAP process.

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