Amicus Therapeutics Announces United Kingdom’s MHRA Grants Early Access to AT-GAA
Amicus Therapeutics, Inc. (FOLD)
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Source: GlobeNewswire
Permits All Eligible Individuals with Late-Onset Pompe Disease Access to AT-GAA Prior to Marketing Authorization in the UK Positive Scientific Opinion Under Early Access to Medicines Scheme (EAMS) Recognizes High Unmet Medical Need in ERT Treated Late-Onset Pompe Disease Patients Positive Scientific Opinion Includes MHRA Review of AT-GAA Phase 3 PROPEL Study Data PHILADELPHIA and MARLOW, United Kingdom, June 08, 2021 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on discovering, developing and delivering novel medicines for rare diseases, today announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a positive scientific opinion through the Early Access to Medicines Scheme (EAMS) to AT-GAA, the Company’s investigational two-component therapy for the treatment of Pompe disease. This positive opinion means that eligible adults living with late-onset Pompe disease (LOPD) who have
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