{"id":"naglazyme","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Antibody formation"},{"rate":null,"effect":"Pyrexia"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Chills"}]},"_chembl":null,"_dailymed":{"setId":"59341250-deac-ed71-3823-a4f5d64dbd77","title":"NAGLAZYME (GALSULFASE) SOLUTION [BIOMARIN PHARMACEUTICAL INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Naglazyme replaces the deficient or absent arylsulfatase B enzyme in patients with MPS VI, enabling the degradation of dermatan sulfate and other glycosaminoglycans that accumulate in tissues and organs. By restoring enzymatic activity, the drug reduces pathological substrate accumulation and slows disease progression. This is an enzyme replacement therapy (ERT) approach to treating a lysosomal storage disorder.","oneSentence":"Naglazyme is a recombinant human arylsulfatase B enzyme that breaks down glycosaminoglycans accumulated in mucopolysaccharidosis VI (MPS VI).","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:56:34.804Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome)"}]},"trialDetails":[{"nctId":"NCT02156674","phase":"NA","title":"Naglazyme After Allo Transplant for Maroteaux-Lamy Syndrome","status":"TERMINATED","sponsor":"Masonic Cancer Center, University of Minnesota","startDate":"2016-01-26","conditions":"Maroteaux-Lamy Syndrome","enrollment":1}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":29,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["recombinant human N-acetylgalactosamine 4-sulfatase","rh-arylsulfatase B","rhASB"],"phase":"marketed","status":"active","brandName":"Naglazyme®","genericName":"Naglazyme®","companyName":"Masonic Cancer Center, University of Minnesota","companyId":"masonic-cancer-center-university-of-minnesota","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Naglazyme is a hydrolytic enzyme used to treat Maroteaux-Lamy Syndrome, a condition caused by a deficiency in the enzyme that breaks down dermatan sulfate. It works by hydrolyzing dermatan sulfate, a type of glycosaminoglycan that accumulates in the bodies of individuals with Maroteaux-Lamy Syndrome.","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2005-05-31T00:00:00.000Z","mah":"BIOMARIN","brand_name_local":"NAGLAZYME","application_number":"BLA125117"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2006-01-23T00:00:00.000Z","mah":"BioMarin International Limited","brand_name_local":"Naglazyme","application_number":"EMEA/H/C/000640"}],"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}