Amicus Therapeutics (FOLD) Announces Approval for Pombiliti + Opfolda by Japan’s Ministry of Health, Labour and Welfare (MHLW)

Amicus Therapeutics, Inc. (NASDAQ:FOLD) is one of the 13 Best Pharma Stocks to Buy According to Wall Street Analysts. On June 25, Amicus Therapeutics, Inc. (NASDAQ:FOLD) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Pombiliti + Opfolda as a treatment of late-onset Pompe disease (LOPD) in adult patients.

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Doctors in a lab coat attending to a patient receiving enzyme replacement therapies.

Pombiliti + Opfolda is a two-component therapy, comprising Pombiliti, a recombinant human GAA enzyme, and Opfolda, an enzyme stabilizer.

The approval was based on clinical data from the Phase 3 pivotal study (PROPEL), which is the only trial in LOPD that studies real-world populations of both ERT-naïve and ERT-experienced participants in a controlled setting. With MHLW’s approval, Pombiliti + Opfolda now holds approval in the US, UK, EU, Canada, Switzerland, Japan, and Australia.

Amicus Therapeutics, Inc. (NASDAQ:FOLD) discovers, develops, and delivers medicines to treat metabolic diseases. Its product portfolio includes the first and only approved oral precision medicine to treat Fabry disease, a clinical-stage treatment paradigm for Pompe disease, and a rare disease gene therapy portfolio.

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