UK's MHRA grants early access to Amicus' AT-GAA
US biotech company Amicus Therapeutics (Nasdaq: FOLD) saw its shares edge up nearly 2% to $10.27 in early trading today, after it 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 received alglucosidase alfa for at least two years can now switch and have access to AT-GAA prior to marketing authorization in the UK.
The EAMS mechanism is intended to provide individuals in the UK who live with a life threatening or seriously debilitating condition early access to innovative and unlicensed medicines for which there is not yet marketing authorization and where there is a clear unmet medical need.
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