WuXi Bio Applauds Amicus on FDA Approval for Pompe Disease Therapy

02 October 2023 | Monday | News

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), congratulates its strategic partner, Amicus Therapeutics ("Amicus") (Nasdaq: FOLD), on receiving U.S. FDA's approval for Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) 65mg capsules. This two-component therapy is indicated for those adults living with late-onset Pompe disease (LOPD) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT).
Image Source : Public Domain

Image Source : Public Domain

Pombiliti™, a recombinant human GAA enzyme (rhGAA) naturally expressed with high levels of bis-M6P (Mannose 6-Phosphate), was started at WuXi Biologics in 2012 with just an initial concept and now realizes commercialization enabled by WuXi Biologics' proprietary integrated technology platform and unparalleled manufacturing capacity. As the exclusive commercial drug substance manufacturing partner and key commercial drug product supplier, WuXi Biologics is now providing commercial manufacturing services for Pombiliti™ at five facilities across its global manufacturing network.

Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, commented, "This approval marks a major milestone for the Pompe disease community in the United States. Bringing this new treatment option to market has required immense dedication and strong partnership between the WuXi Biologics team and Amicus, relying on our shared dedication to patients and our ability to execute on our vision to bring high quality therapies to the rare disease community. Over many years of hard work, our joint efforts have brought this medicine from an idea, to a molecule, to clinical manufacturing and commercial supply, delivering on our commitment to people living with late-onset Pompe disease."

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We're honored to enable Amicus to achieve this great milestone, which we've been looking forward to for over 11 years. This close partnership not only showcases our successful strategy, 'follow the molecule', but also inspires us to accelerate the discovery, development and manufacturing of more rare disease biologic therapeutics for global partners. I am confident that the collaboration between our two companies, both of which share a passion for patients, will achieve greater successes in the journey of benefiting global patients with rare diseases."


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