for injection, for intravenous use
XENPOZYME is a hydrolytic lysosomal sphingomyelin-specific enzyme indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients
Facts about olipudase alfa-rpcp
Approval Date: 8/31/2022
Proprietary Name: Xenpozyme
Active Ingredient(s): olipudase alfa-rpcp
FDA-approved use: To treat acid sphingomyelinase deficiency
Dosage Form: Injection
Dosage Forms And Strengths: For injection: 20 mg of olipudase alfa-rpcp as a lyophilized powder in a single-dose vial for reconstitution.
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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Query For olipudase alfa-rpcp
Approved accessible "olipudase alfa-rpcp"
XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. Olipudase alfa, sold under the brand name Xenpozyme, is a medication used for the treatment of non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) type A/B or type B.
Xenpozyme is the first ASMD-specific treatment. This medicine is an enzyme replacement therapy, developed to replace patients' deficient or defective enzyme, acid sphingomyelinase (ASM), and thereby reduce fat accumulation within cells and relieve some of the symptoms of the disease. The highest potential for clinical benefit is expected in patients with chronic visceral forms of ASMD (type B). The replacement enzyme is produced by a method known as recombinant DNA technology: it is made by cells into which a gene (DNA) has been introduced, that enables them to produce the enzyme. Olipudase alfa was approved for medical use in Japan in March 2022, in the European Union in June 2022, and in the United States in August 2022. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.
How can 1 go about obtaining olipudase alfa-rpcp?
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XENPOZYME (olipudase alfa-rpcp) for injection, for intravenous use
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