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As Shire gives up on Replagal in U.S., Sanofi stands to gain
Shire pulled its application for approval of Replagal, the Fabry treatment it has been providing to 140 U.S. patients free of charge during the Fabrazyme shortage.
Replagal 1mg/ml concentrate for solution for infusion - medicines
Replagal treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases. Posology Replagal is administered at a dose of 0.2 mg/kg body weight every other week by intravenous infusion over 40 minutes.
Replagal | European Medicines Agency
Replagal is an enzyme-replacement therapy. Enzyme-replacement therapy provides patients with the enzyme they are lacking. Replagal is designed to replace the human enzyme alpha-galactosidase A, which is lacking in people with Fabry disease.
Replagal Enzyme Replacement Therapy for Adults With Fabry ...
As a result, the lipid accumulates in the body, causing problems with the kidneys, heart, nerves, and blood vessels. This study will examine whether replacing the missing alpha-galactosidase A with a genetically engineered form of the enzyme called Replagal can reverse the illness.
Frequently Asked Questions About Replagal for Fabry Disease
Replagal is a treatment for Fabry disease patients ages 7 and older. Shire (now owned by Takeda) developed it. Although in use in many countries, including those of the European Union, the U.S. Food and Drug Administration (FDA) has not approved Replagal.
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