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Pombiliti (cipaglucosidase alfa-atga) plus Opfolda™ (miglustat) – New drug approvals

September 28, 2023 - Amicus Therapeutics announced the FDA approval of Pombiliti (cipaglucosidase alfa-atga) plus Opfolda (miglustat), for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥ 40 kg and who are not improving on their current enzyme replacement therapy (ERT).

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