RegulationConditional marketing approval (China), Overseas New Drugs Urgently Needed in Clinical Settings (China), Orphan Drug (Japan), Priority Review (China)

Structure/Sequence

Sequence Code 4987

Source: *****

Clinical Trials associated with Agalsidase alfa

NCT05067868

/ Active, not recruitingPhase 4

A Prospective, Open-label, Multicentre, Interventional, Single-arm, Phase IV Study to Evaluate the Safety and Efficacy of Agalsidase Alfa (r-DNA Origin) (Replagal™) in Indian Children and Adults With Fabry Disease

The main aim of this study is to learn more about the safety profile of Replagal.
Participants will receive Replagal every 2 weeks at the clinic for about 1 year.

Start Date01 Nov 2022

Sponsor / Collaborator

Shire Plc

CTR20220105

/ CompletedPhase 3

一项评价瑞普佳用于治疗中国法布雷病初治受试者的安全性、疗效和药代动力学的开放标签研究

[Translation] An open-label study evaluating the safety, efficacy, and pharmacokinetics of Ripuga in treatment-naïve Chinese subjects with Fabry disease

主要目的：通过评价整个研究期间在治疗中出现的严重不良事件（TEAE）的发生率来评估瑞普佳在中国法布雷病初治受试者中的安全性。次要目的： 1.评价瑞普佳的其他安全性参数; 2.评价瑞普佳对肾功能参数（估算肾小球滤过率 [eGFR]）的疗效； 1）评价瑞普佳对其他肾功能变量、疼痛以及药效学（PD）标记物（血浆 lyso-Gb3）的疗效 2）在年龄 <18 岁的受试者中评价听力变化 3）评价瑞普佳在中国法布雷病初治受试者中的药代动力学（PK）。

[Translation]

Primary objective: To evaluate the safety of Ripuga in Chinese Fabry disease naïve subjects by evaluating the incidence of treatment-emergent serious adverse events (TEAEs) throughout the study. Secondary objectives: 1. To evaluate other safety parameters of Ripuga; 2. To evaluate the efficacy of Ripuga on renal function parameters (estimated glomerular filtration rate [eGFR]); 1) To evaluate the efficacy of Ripuga on other renal function variables, pain, and pharmacodynamic (PD) markers (plasma lyso-Gb3); 2) To evaluate hearing changes in subjects aged <18 years; 3) To evaluate the pharmacokinetics (PK) of Ripuga in Chinese Fabry disease naïve subjects.

Start Date01 May 2022

Sponsor / Collaborator

Dhl Supply Chain Netherlands BV

[+3]

NCT04974749

/ CompletedPhase 3

An Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of REPLAGAL® in Treatment-naïve Chinese Subjects With Fabry Disease

The main aim of the study is to assess the safety of REPLAGAL. Study participants will receive REPLAGAL as an intravenous infusion every other week for 52 weeks. Participants will visit their study clinic many times throughout the study.

Start Date01 May 2022

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

100 Clinical Results associated with Agalsidase alfa

100 Translational Medicine associated with Agalsidase alfa

100 Patents (Medical) associated with Agalsidase alfa

237

Literatures (Medical) associated with Agalsidase alfa

01 Jun 2025·Molecular Genetics and Metabolism Reports

Two decades of experience of the Fabry Outcome Survey provides further confirmation of the long-term effectiveness of agalsidase alfa enzyme replacement therapy

Article

Author: Nicholls, Kathleen ; Niu, Dau-Ming ; Schenk, Jörn ; West, Michael L ; Giugliani, Roberto ; Hughes, Derralynn A ; Reisin, Ricardo ; Jazukeviciene, Dalia ; Kampmann, Christoph ; Anagnostopoulou, Christina ; Pintos-Morell, Guillem ; Botha, Jaco ; Ramaswami, Uma

BackgroundAnalyses of up to 20 years of data from the Fabry Outcome Survey (FOS) assessed the long-term effectiveness of agalsidase alfa enzyme replacement therapy.MethodsThe impact of agalsidase alfa treatment on renal, cardiac, morbidity, and mortality outcomes in FOS was compared with untreated external Fabry disease (FD) cohorts.ResultsA total of 2171 FOS patients (1014 men, 919 women, 163 boys, 75 girls) received agalsidase alfa (median [range] duration of treatment: 5.38 [0.0-20.8] years). Annual rates of decline in estimated glomerular filtration rate improved in treated patients versus untreated external cohorts regardless of sex or baseline urinary protein levels. Annual left ventricular mass index rates were stable in treated patients regardless of sex or baseline left ventricular hypertrophy status, and better than in untreated external cohorts. The mean age at which 50 % of patients had their first composite morbidity event was later in the agalsidase-alfa-treated population than in the untreated external cohort (51.7 vs 41 years [males]; 60.8 vs 53 years [females]). After 24 months of treatment, the probability of a composite morbidity event was ∼34 % in treated patients and ∼ 45 % in untreated patients. Treated patients were older at death than untreated patients (mean [range]: 61.7 [26.2-87.6] vs 50.3 [34.5-70.1] years). The mean age at which 50 % of male patients were still alive was higher in treated patients than in untreated external cohorts (75.5 vs 60.0 years).ConclusionsLong-term treatment with agalsidase alfa may provide renal, cardiac, and overall survival protection in FD.

01 Feb 2025·Advances in Therapy

Effects of Current Therapies on Disease Progression in Fabry Disease: A Narrative Review for Better Patient Management in Clinical Practice

Review

Author: Pieruzzi, Federico ; Cianci, Vittoria ; Tuttolomondo, Antonino ; Pisani, Antonio ; Biagini, Elena ; Mignani, Renzo ; Pieroni, Maurizio

Fabry disease (FD) is a rare lysosomal storage disorder that is characterized by renal, neurological, and cardiovascular dysfunction. Four treatments are currently available for patients with FD; three enzyme replacement therapies (ERTs; agalsidase alfa, agalsidase beta, and pegunigalsidase alfa) and one pharmacological chaperone (migalastat). This review focuses on the evidence for the benefits of ERTs and migalastat, and provides an overview of their impact on disease manifestations and quality of life (QoL). Agalsidase beta is associated with renal, neurological, and cardiovascular benefits, and may prevent renal disease progression. Agalsidase alfa provides stabilizing effects across all main organ systems, although minor sex-specific differences exist in patients with more advanced baseline disease. The benefits of agalsidase alfa and agalsidase beta are similar but depend on the extent of baseline disease. Some data indicate that agalsidase beta may be preferable over the longer term. Both agalsidase alfa and agalsidase beta are associated with improved gastrointestinal and pain symptoms, as well as improved QoL. Patients with advanced end-organ damage tend not to respond as optimally to ERTs as those who initiate ERTs before irreversible organ fibrosis develops, highlighting the need for early treatment initiation. Migalastat, which is only approved for patients with amenable missense gene variants, generally stabilizes renal parameters and provides cardiovascular benefits. Migalastat also improves diarrhea and pain, and stabilizes QoL (although ERT may be more effective for pain management), but the neurological effects of migalastat have not been studied. Real-world data raise concerns about effective in vivo amenability of some genetic variants. Future studies with direct treatment comparisons in patients with FD are needed.

01 Jan 2025·Journal of Inherited Metabolic Disease

A phase III, open‐label clinical trial evaluating pegunigalsidase alfa administered every 4 weeks in adults with Fabry disease previously treated with other enzyme replacement therapies

Article

Author: Longo, Nicola ; Chertkoff, Raul ; Wilcox, William R. ; Waldek, Stephen ; Hughes, Derralynn ; Eyskens, François ; Goker‐Alpan, Ozlem ; Pisani, Antonio ; Alon, Sari ; Sakov, Anat ; Holida, Myrl ; Bernat, John A. ; Rocco, Rossana ; Deegan, Patrick ; Feldt‐Rasmussen, Ulla ; Wallace, Eric ; Almon, Einat Brill ; Tøndel, Camilla ; Warnock, David G. ; Linhart, Aleš

AbstractPegunigalsidase alfa, a PEGylated α‐galactosidase A enzyme replacement therapy (ERT) for Fabry disease, has a longer plasma half‐life than other ERTs administered intravenously every 2 weeks (E2W). BRIGHT (NCT03180840) was a phase III, open‐label study in adults with Fabry disease, previously treated with agalsidase alfa or beta E2W for ≥3 years, who switched to 2 mg/kg pegunigalsidase alfa every 4 weeks (E4W) for 52 weeks. Primary objective assessed safety, including number of treatment‐emergent adverse events (TEAEs). Thirty patients were enrolled (24 males); 23 previously received agalsidase beta. Pegunigalsidase alfa plasma concentrations remained above the lower limit of quantification throughout the 4‐week dosing interval. Thirty‐three of 182 TEAEs (in 9 patients) were considered treatment‐related; all were mild/moderate. No patients developed de novo anti‐drug antibodies (ADAs). In the efficacy analysis (n = 29), median (inter‐quartile range) eGFR change from baseline over 52 weeks was −1.9 (−5.9; 1.8) mL/min/1.73 m2 (n = 28; males [n = 22]: –2.4 [−5.2; 3.2]; females [n = 6]: −0.7 [−9.2; 2.0]). Overall, median eGFR slope was –1.9 (−8.3; 1.9) mL/min/1.73 m2/year (ADA‐negative [n = 20]: −1.2 [−6.4; 2.6]; ADA‐positive [n = 9]: −8.4 [−11.6; –1.0]). Lyso‐Gb3 concentrations were low and stable in females, with a slight increase in males (9/24 ADA‐positive). The BRIGHT study results suggest that 2 mg/kg pegunigalsidase alfa E4W is tolerated well in stable adult patients with Fabry disease. Due to the low number of patients in this study, more research is needed to demonstrate the effects of pegunigalsidase alfa given E4W. Further evidence, outside of this clinical trial, should be factored in for physicians to prolong the biweekly ERT intervals to E4W.Take‐home messageTreatment with 2 mg/kg pegunigalsidase alfa every 4 weeks could offer a new treatment option for patients with Fabry disease.

News (Medical) associated with Agalsidase alfa

23 Jan 2025

·fabrydiseasenews.com

ERT treatment guidelines lead to stable Fabry in women: Study

Women severely affected by Fabry disease and treated with enzyme replacement therapy (ERT) and untreated women with less severe symptoms showed broadly stable disease course over five years, a study in Germany found.Treatment decisions were primarily based on the European guidelines for females with Fabry, which recommend initiating treatment at the first manifestation of Fabry-related organ involvement or pain. The guidelines “appear to have been correct” for most of the women in the study, the researchers wrote. Still, “it is crucial to explore if organ involvement is [Fabry]-related in order to make the correct treatment decision,” they wrote.The study, “Impact of enzyme replacement therapy on clinical manifestations in females with Fabry disease,“ which was published in the Orphanet Journal of Rare Diseases.According to current European guidelines, ERT for female Fabry patients should start after the first manifestation involving the kidneys, heart, or nervous system, or if pain or severe gastrointestinal complaints are present.A previous study from the research team suggested that treatment for women with Fabry in that country generally aligns with the current European Fabry guidelines. Still, one-third of patients were left untreated despite organ involvement.In Fabry, mutations in the GLA gene disrupt the production and/or function of the enzyme alpha-galactosidase A (alpha-Gal A). A lack of this enzyme’s activity leads to the toxic build-up of fatty substances called globotriaosylceramide (Gb3) and lyso-Gb3 in the body’s cells, particularly in the heart, kidneys, and nervous system.Because the GLA gene is located on the X chromosome, males with one copy of the gene tend to have more severe symptoms that develop earlier than females with two copies. For females, even if one copy of the GLA gene is mutated, the second copy is typically normal, so disease onset, progression, and severity varies more than in males.The researchers said this discrepancy means more data are required for female patients to analyze the effect of ERT or to exclude potential disease progression in untreated females. They retrospectively analyzed data from 159 women with Fabry collected at three visits at six Fabry centers in Germany. All participants were either untreated with ERT or on a stable dose of agalsidase alfa, sold as Replagal outside the U.S., or agalsidase-beta, sold as Fabrazyme, for at least six months.Seventy-one patients were untreated, 47 were newly treated, and 41 had received long-term ERT. The untreated group was significantly younger, had the lowest blood levels of lyso-Gb3, and had the least frequent Fabry-related symptoms and manifestations, including edema (swelling), pain, fatigue, and heart involvement.The newly ERT-treated group had the highest blood pressure values and showed more frequent albuminuria, a sign of kidney disease. Median eGFR values, a test for kidney function, and the number of ischemic attacks/strokes were similar before the first visit across all three groups.Fabry-related pain was the most frequent initial manifestation in all three groups, followed by heart and kidney involvement. Gastrointestinal symptoms were reported by 37.3% of untreated patients.About 90% of patients who received ERT showed at least one organ manifestation, with most having two or more, “justifying treatment according to current European guidelines,” the team noted. In contrast, one in four untreated patients showed no organ damage or manifestations at the first visit, and one-third had more than one manifestation.Between the first and third visits, transient ischemic attacks/strokes occurred more often among newly ERT-treated patients than in untreated and long-term ERT patients. Four of the five newly treated patients who experienced these events had no history of such complications.At the same time, heart involvement remained stable across all three groups. No pacemakers for irregular heartbeats were needed among untreated patients, while nearly one in ten (8.5%) newly treated patients and one in 20 (4.5%) long-term ERT patients required pacemakers.Mean eGFRs for kidney function in newly treated and long-term ERT-treated patients slightly decreased over time, but remained stable within the untreated group. The albumin-to-creatinine ratio from urine, another kidney function test, was stable in all three groups over time.Disease severity slightly increased over time in all groups, as indicated by the Disease Severity Scoring System (DS3) and the Mainz Severity Score Index (MSSI). Blood tests showed lyso-Gb3 values in the newly ERT-treated group dropped significantly over time while remaining stable in the other two groups.“Both severely affected females who were treated and less severely affected untreated females showed a broadly stable disease course over 5 years,” the researchers wrote. “The treatment decisions based on the European guidelines appear to have been correct in most patients of our cohort.”

Clinical ResultAHA

10 Dec 2024

·www.pharmaceutical-technology.com

EMA validates Chiesi and Protalix’s dose variation for Fabry disease

The EC granted marketing authorisation to the therapy to treat Fabry disease in adults in May 2023. Credit: bangoland/Shutterstock. The European Medicines Agency (EMA) has validated Chiesi Global Rare Diseases and Protalix BioTherapeutics ’ submission to update the dosing regimen of pegunigalsidase alfa, used in treating Fabry disease, a rare genetic lysosomal storage disorder. The proposed regimen suggests a dose of 2 mg/kg body weight administered every four weeks for adults, a modification from the currently approved bi-weekly 1 mg/kg dose. Chiesi and Protalix’s variation application for pegunigalsidase alfa’s new dosing regimen is backed by a revised population-PK model, new exposure-response analyses and clinical data from the completed Phase III BRIGHT trial and its ongoing extension study. The studies explored the 2mg/kg every four weeks dosing for adults previously treated with agalsidase-alfa or beta. Chiesi Global Rare Diseases executive vice-president Giacomo Chiesi said: “The validation of this variation application is an important milestone in our efforts to reduce the burden of treatment for some adult patients living with Fabry disease who continue to experience unmet medical needs. “We are committed to delivering innovative therapies and solutions for people living with Fabry disease, their families and caregivers.” A biopharmaceutical company, Protalix leverages its plant cell-based expression system, ProCellEx, to develop recombinant therapeutic proteins. Pegunigalsidase alfa, the company’s second product, received approval from both the US Food and Drug Administration (FDA) and the EMA in May 2023. In the same month, the European Commission granted marketing authorisation to the therapy to treat the condition. Protalix BioTherapeutics CEO and president Dror Bashan stated: “Based on study results, we believe in the potential of pegunigalsidase alfa 2 mg/kg administered every four weeks to be a beneficial alternative dosing option for some adults living with Fabry disease. “Together with Chiesi, we remain committed to meeting the needs of people with Fabry disease and bringing additional therapeutic options to market. We look forward to continuing to work closely with the agency in the months ahead.” The partnership between Chiesi Farmaceutici and Protalix focuses on the development and commercialisation of pegunigalsidase alfa worldwide. Chiesi Global Rare Diseases is a business division of the Chiesi Group.

Phase 3Drug ApprovalBiosimilar

14 Nov 2024

·fabrydiseasenews.com

Boy with Fabry disease diagnosed with co-occurring blood disorder

A 10-year-old boy diagnosed with Fabry disease was also found to have a rare blood disorder called congenital dyserythropoietic anemia (CDA) in a case researchers said was highly unusual.In CDA, anemia, that is, a shortage of red blood cells that transport oxygen in the bloodstream, results in symptoms like fatigue, weakness, and pale skin.“CDA … and [Fabry disease] co-occurring in the same patient is a very rare medical finding [that] has never been reported,” the researchers wrote. “This case … underscores the need for further investigation into potential genetic and [disease-causing] links between these seemingly disparate conditions.”The case was described in “The unlikely combination: Anderson–Fabry disease and congenital dyserythropoietic anemia type II in a pediatric patient,” in Clinical Case Reports.The boy was started on treatment with agalsidase alfa, an enzyme replacement therapy for Fabry, but no follow-up data regarding his treatment outcomes was provided.Fabry disease is caused by mutations in the GLA gene, which provides instructions for producing the alpha-galactosidase A (alpha-Gal A) enzyme. The mutations typically affect the activity of alpha-Gal A and lead to fat molecules — mainly globotriaosylceramide (Gb3) and lyso-Gb3 — accumulating in several tissues and organs. Symptoms include pain, gastrointestinal issues, and skin rash, and may involve the kidneys, heart, and nervous system.The boy was admitted to a pediatric clinic having had a pale appearance and recurrent infections in the previous months. A physical exam showed his vital signs were stable and he had normal growth, but an ultrasound revealed an enlarged spleen.Laboratory work indicated low hemoglobin, the protein that carries oxygen in red blood cells, and high levels of total bilirubin, although direct bilirubin was in the normal range. Total bilirubin includes indirect bilirubin, the one that results from the breakdown of red blood cells, and direct bilirubin, an indicator of liver function.The boy had ferritin levels that were just above the lower normal range. Ferritin is a protein that stores iron needed to make healthy red blood cells. The boy was treated with folic acid and iron supplements, which didn’t significantly increase his hemoglobin or reduce the levels of total bilirubin.Whole genome sequencing, which allows for the sequencing of a person’s complete genetic information, revealed genetic mutations consistent with Fabry disease, which, together with lower than normal alpha-GalA activity confirmed the disease diagnosis.The boy also had a mutation that led to a CDA type 2 diagnosis. This CDA type is the most common one and is marked by anemia, and liver and spleen enlargement. He was referred to a pediatric neurologist and started treatment with agalsidase alfa every two weeks. Agalsidase alfa is an enzyme replacement therapy, meaning it provides a working version of the alpha-Gal A enzyme to ease Fabry symptoms. The treatment is approved as Replagal in Europe and other countries, but not in the U.S.No information about the result of treatment was provided by the researchers.“The combined form of both entities of disorders isn’t widely known. Since both CDA and [Fabry disease] are rare genetic disorders, the likelihood of an individual having both conditions simultaneously is exceedingly low,” the researchers wrote. “To the best of our knowledge, it is the first case of [Fabry disease] and CDA type II, coexisting in a 10-year-old boy.”

Drug ApprovalClinical Result

100 Deals associated with Agalsidase alfa

External Link

KEGG	Wiki	ATC	Drug Bank
D02784	Agalsidase alfa	A16AB03	DB15874

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fabry Disease	Iceland	Takeda Pharmaceuticals International AG	03 Aug 2001
Fabry Disease	European Union	Takeda Pharmaceuticals International AG	03 Aug 2001
Fabry Disease	Norway	Takeda Pharmaceuticals International AG	03 Aug 2001
Fabry Disease	Liechtenstein	Takeda Pharmaceuticals International AG	03 Aug 2001

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fabry Disease	Preclinical	United States	Shire Plc	29 Dec 2008
Fabry Disease	Preclinical	Paraguay	Shire Plc	29 Dec 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04974749 (CTgov)	Phase 3	Fabry Disease	20	REPLAGAL	incnzckdxw(oypvgzovis) = uqvmwzqkoa ogwvzkzjye (eexjfaxnzg, szinbzgvxz - xebfnzsesq) View more	-	08 Oct 2024
NCT04840667 (CTgov)	Phase 3	Fabry Disease	17	REPLAGAL	meqwdaxjmg(brsmfldoyy) = ahniflidgv wnkwdhfzmc (pdjbaeslqt, rgrkwljymg - adlwoveomx) View more	-	17 Jun 2024
NCT01298141 (Pubmed \| Drugs R D) Manual	Phase 3	Fabry Disease	167	Agalsidase alfa	(oozygxhyyi) = rztzahetuc tqnyjlhzxw (zawjhwaztt ) View more	Positive	01 Dec 2021
SSIEM2019	Not Applicable	Fabry Disease	493	Agalsidase alfa	yxtsemxxta(xpbvgphcgh) = wviqqqhccg smkrjnjybr (jgicdxmswk ) View more	Positive	25 Aug 2019
SSIEM2019	Not Applicable	Fabry Disease	138	agalsidase alfa	wjxoesqunn(nihsamjnel) = uymgwuhxzr vxnjzkodvf (effuzgnoeb ) View more	-	25 Aug 2019
SSIEM2019	Not Applicable	Fabry Disease	138	agalsidase alfa	wjxoesqunn(nihsamjnel) = iihqvgchkd vxnjzkodvf (effuzgnoeb ) View more	-	25 Aug 2019
NCT01218659 (ATTRACT \| FACETS, CTgov)	Phase 3	Fabry Disease	68	Migalastat (Migalastat (0-18 Months))	miruefdosp(ejyetbvwmt) = stpjyahqrk esxpghcidw (owtsoowtzt, olhjtwmokr - phoznsznjl) View more	-	01 Nov 2018
NCT01218659 (ATTRACT \| FACETS, CTgov)	Phase 3	Fabry Disease	68	agalsidase beta+agalsidase alfa+migalastat (ERT (0-18 Months))	miruefdosp(ejyetbvwmt) = fdgapjrcxr esxpghcidw (owtsoowtzt, zwilrbuwyu - gjuekpuxya) View more	-	01 Nov 2018
NCT01363492 (HGT-REP-084, Pubmed \| Drug Des Devel Ther) Manual	Phase 2	Fabry Disease	14	agalsidase alfa	ghtserywbd(iugqahyuwg) = qchkmkyxfq eybflnoxjg (ymtaxxanyb ) View more	Positive	25 May 2016
NCT01124643 (CTgov)	Phase 3	Fabry Disease	35	Replagal	hydjuojpho(bnnctnsfju) = xagtwcwgup tpootkyqug (qdbqqsiowx, yfprsaxwny - mudifuliny) View more	-	22 Aug 2014
NCT01363492 (HGT-REP-084, CTgov)	Phase 2	Fabry Disease	15	Replagal (Replagal (0.2 mg/kg))	pmrcifiihs(qftthpiffh) = vhkqwkpyxq telynjqybn (fvpprqskvx, jewiorxpoj - vxcthavbhj) View more	-	20 May 2014
NCT01363492 (HGT-REP-084, CTgov)	Phase 2	Fabry Disease	15	Replagal (Replagal 0.2 mg/kg)	prccfwidcc(qsvvlkrfkr) = zbvhmxqbed cheqsxlhbp (ppeetvipeu, httnlortvl - lenpxefxsj) View more	-	20 May 2014
NCT01304277 (CTgov)	Phase 2	Fabry Disease	17	agalsidase alfa	gklmbkcjta(qfoboywgmk) = kugiwywdoi phwuooyohy (zsxxwaydgp, ptikzcqdbv - ieesysojqp) View more	-	25 Apr 2014

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