We are pleased to share that Chiesi has received the UK Medicines and Healthcare products Regulatory Agency (MHRA) approval for an additional dosing regimen of 2mg/kg administered every four weeks for pegunigalsidase alfa in adults stable with an enzyme replacement therapy.
Pegunigalsidase alfa is a long-term enzyme replacement therapy for adults living with Fabry disease. This change to the dosing schedule would lessen the treatment burden for eligible individuals with Fabry in the UK by reducing infusion frequency from biweekly to once every four weeks.
Bob Stevens, MPS Society Group CEO, said:
"People living with Fabry disease plan their lives around treatment. The possibility of attending infusions once every four weeks instead of two would offer greater flexibility and may help ease some of the practical challenges that come with long-term treatment. It is encouraging to see continued efforts to deliver options that may better reflect the needs of the Fabry community."
It is encouraging to see continued efforts to deliver options that may better reflect the needs of the Fabry community.
Derralynn Hughes, MPS Society trustee, Professor of Experimental Haematology, Director of Research and Innovation and Co-Clinical Director of the NCL Cancer Alliance comments:
“For many people living with Fabry disease, regular fortnightly infusions can have a significant impact on day-to-day life, affecting work, family routines and overall quality of life. The patient community consistently highlights the need for treatment approaches that help reduce this burden where clinically appropriate, and we look forward to being able to offer infusions every-four-weeks to those who are stable on their current ERT, with appropriate monitoring.”
We look forward to being able to offer infusions every-four-weeks to those who are stable on their current ERT, with appropriate monitoring.”
