RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (South Korea), Orphan Drug (Australia)

Structure/Sequence

Sequence Code 13505337

Source: *****

Clinical Trials associated with Avalglucosidase alfa ngpt

CTIS2024-514255-15-01

/ RecruitingPhase 4

Open label, single-center pilot study to investigate enzyme replacement therapy (ERT) frequency reduction from 2 to 4 weeks in a subgroup of elderly patients with late-onset Pompe disease

Start Date26 Jun 2025

Sponsor / Collaborator

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

NCT06666413

/ RecruitingPhase 4

A Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Avalglucosidase Alfa in Chinese Participants With Infantile-onset Pompe Disease (IOPD)

This is a single group, 52-week treatment, Phase 4, open-label, single-arm study to assess the safety and efficacy of avalglucosidase alfa IV infusion in male and female Chinese participants with IOPD who are treatment-naïve or were previously treated with ERT.
Study details include:
* The study duration: total study duration is approximately 64 weeks.
* Screening period of up to 8 weeks
* Treatment period of 52 weeks
* Follow-up period of 4 weeks. (if the participant enrolls in another study or receives commercially available ERT, the follow-up period may be reduced from 4 to 2 weeks)
* The number of visits will be 30, including 29 site visits and 1 phone call follow-up visit.

Start Date07 May 2025

Sponsor / Collaborator

Genzyme Corp.

NCT06121011

/ RecruitingNot Applicable

A Global Prospective Observational Registry of Patients With Pompe Disease

This is a global, multicenter, prospective, observational registry of patients with Pompe disease, including those with late-onset pompe disease (LOPD) and infantile-onset pompe disease (IOPD). Both untreated patients and those being treated with an approved therapy for Pompe disease are eligible to participate.
The objectives of the registry are:
* To evaluate the long-term safety of Pompe disease treatments through collection of data that describe the frequency of adverse events (AEs)/serious adverse events (SAEs) occurring in Pompe disease patients
* To evaluate the long-term real-world effectiveness of Pompe disease treatments
* To evaluate the long-term real-world impact of Pompe disease treatments on quality of life (QOL) and patient-reported outcomes (PROs)
* To describe the natural history of untreated Pompe disease

Start Date16 Feb 2024

Sponsor / Collaborator

Amicus Therapeutics, Inc.

100 Clinical Results associated with Avalglucosidase alfa ngpt

100 Translational Medicine associated with Avalglucosidase alfa ngpt

100 Patents (Medical) associated with Avalglucosidase alfa ngpt

Literatures (Medical) associated with Avalglucosidase alfa ngpt

01 Sep 2026·INDIAN JOURNAL OF PEDIATRICS

Impact of Enzyme Replacement Therapy on Patients with Late Onset Pompe Disease – Real World Data from a Developing Country

Article

Author: Yesodharan, Dhanya ; Pal, Swasti ; Jagadeesh, Sujatha ; Gupta, Neerja ; Vh, Sankar ; Kishnani, Priya S ; Puri, Ratna Dua ; Gn, Sanjeeva ; Bijarnia-Mahay, Sunita ; Kabra, Madhulika ; Modani, Prerana ; Bhat, Meenakshi ; Nampoothiri, Sheela ; Muranjan, Mamta

OBJECTIVES:

To determine the impact of enzyme replacement therapy (ERT) in patients with late onset Pompe disease (LOPD) in terms of change in motor and respiratory status, along with challenges in obtaining multi-disciplinary care to manage the multi-systemic aspects of disease.

METHODS:

This was a retrospective chart review of patient data, collected from seven tertiary care centres across India. All patients of late onset Pompe disease that have received enzyme replacement therapy were included and a descriptive analysis of data was performed.

RESULTS:

Twenty two patients of LOPD were initiated on ERT and included in this data analysis, with demise of three patients and incomplete follow-up of five patients. Motor function assessment, in terms of 6 min walk test (6MW) and change in ambulatory status, showed improvement/stabilization of distance walked in 6 min for three of four patients, although one of three lost ambulation thereafter due to severe COVID infection. One patient showed gradual deterioration in 6 MW distance with 6.7% minimal detectable change for 4 patients. Fifteen percent (15%) patients lost independent ambulation over the study period. Of eight patients with pulmonary function test data before and after ERT, four showed decline while four showed stabilization of supine and sitting forced vital capacity. Three patients developed sleep disordered breathing requiring nocturnal BiPAP. Five patients were switched over to avalglucosidase alfa from alglucosidase alfa, with two patients showing improvement in PFT after switching over.

CONCLUSIONS:

This is the first study describing the impact of ERT in an Indian cohort of LOPD patients. It shows real world concerns of impact of chronic diseases with delay in starting therapy. It also brings to light the challenges in obtaining multi-disciplinary management. The wide variability in spectrum of presentations, early onset and faster rates of disease progression as well as high disease burden highlight the need for early initiation of therapy.

01 Jul 2026·EUROPEAN JOURNAL OF NEUROLOGY

Real‐Life Effectiveness After Switching to Avalglucosidase Alfa in Late‐Onset Pompe Disease Patients Worsening on Alglucosidase Alfa Therapy: A French Cohort Study

Article

Author: Arrassi, Azzeddine ; Nollet, Sylvain ; Taouagh, Nadjib ; Sacconi, Sabrina ; Magot, Armelle ; Davion, Jean‐Baptiste ; Fournier, Maxime ; Chitimus, Diana ; Cintas, Pascal ; Laforêt, Pascal ; Deibener‐Kaminsky, Joëlle ; Bouhour, Françoise ; Lefeuvre, Claire ; Hamroun, Dalil ; Renard, Dimitri ; Noury, Jean‐Baptiste ; Beltran, Stephane ; Spinazzi, Marco ; Michaud, Maud ; Tard, Céline ; Demurger, Florence ; Attarian, Shahram ; Salort‐Campana, Emmanuelle ; Lagrange, Emmeline

ABSTRACT:

Late‐onset Pompe disease (LOPD) is a progressive myopathy. Enzyme replacement therapy is effective, but long‐term outcomes vary. Avalglucosidase alfa, shown to be non‐inferior to alglucosidase alfa in a phase 3 trial, became available in France through compassionate use for patients with insufficient response to alglucosidase alfa.

Methods:

Data from the French Pompe registry were analyzed for patients who switched to avalglucosidase alfa with at least 1 year of follow‐up. Respiratory function (forced vital capacity, FVC) and motor function evaluated with gait performance (Six‐Minute Walk Test, 6MWT) were assessed before the switch, and one and 2 years after. Individual changes were compared using paired‐sample tests.

Results:

Forty‐seven adult patients were included. A stabilization of motor decline was observed: prior to switching, the 6MWT decreased by −27 m/year, whereas an improvement of +17 m/year was seen during the first year after the switch ( p = 0.001), followed by overall stability in the second year (−10 m/year, p = 0.280). Respiratory changes were not statistically significant: a decline of 60 mL/year before the switch versus 10 mL/year after 1 year ( p = 0.161), and 20 mL/year during the second year ( p = 0.346). Three patients died during follow‐up, with causes unrelated to the disease or treatment.

Discussion:

Gait deterioration halted during the first year after transitioning to avalglucosidase, with sustained stabilization thereafter, while respiratory parameters showed minimal change. For patients experiencing significant walking decline under alglucosidase alfa therapy, switching to avalglucosidase alfa resulted in disease stabilization, beginning with mild improvement in the first year and a return to pre‐switch baseline thereafter.

01 Jun 2026·MOLECULAR GENETICS AND METABOLISM

Early enzyme replacement therapy in late-onset Pompe disease diagnosed by newborn screening

Article

Author: Makhijani, Neelam ; Nading, Erica ; McMechan, Deborah R ; Jones, Harrison N ; Huggins, Erin ; Kishnani, Priya S ; Case, Laura E ; Hobson-Webb, Lisa D ; Moore, Steven A

OBJECTIVE:

Newborn screening (NBS) now allows for early detection and clinical monitoring in infants and children with late-onset Pompe disease (LOPD), potentially identifying those needing early enzyme replacement therapy (ERT). Early symptom onset has been reported in LOPD, but with a paucity of information on when to initiate ERT and on outcomes with early treatment. We report our experience at Duke University Medical Center with seven symptomatic children diagnosed with LOPD by NBS, compound heterozygous for the common IVS1 variant c.-32-13 T > G and a second pathogenic or likely pathogenic variant, started early on ERT.

METHODS:

All participants underwent periodic multidisciplinary evaluations including kinematic analysis of posture/movement; standardized assessments of gross motor, speech-language, and feeding/swallowing; serum and urine biomarker analysis; and quantitative muscle ultrasound.

RESULTS:

Prior to initiation of ERT, all participants showed kinematic deficits and persistently elevated serum creatine kinase (CK). Median age at ERT initiation was 8.2 months (range: 2-20 months) with 6/7 showing standardized motor scores ≤10th percentile +/or declining. All started on alglucosidase alfa, later transitioning to avalglucosidase alfa without complications. At latest evaluation, all demonstrated motor improvement and normalization of CK.

CONCLUSION:

Data presented here supports existing evidence that infants and children with LOPD can present with early symptom onset and may benefit from early ERT. While further study is needed, we showcase the early features of LOPD, benefits from early ERT, and the importance of comprehensive multidisciplinary evaluation of LOPD diagnosed via NBS, allowing timely intervention for those that may benefit from early ERT.

News (Medical) associated with Avalglucosidase alfa ngpt

23 Jul 2026

·healthcare-digital.com

Sanofi's Executive Leadership Reshuffle: The Key Changes

Sanofi's leadership refresh follows a a busy first half of 2026, marked by a series of regulatory milestones and pipeline advances. Credit: Sanofi. Sanofi’s revamped executive team brings leaders from across the company’s key global functions to support its “next strategic chapter” and future growth Sanofi has announced a reshaped Executive Committee and key leadership changes as the pharmaceutical giant prepares for its next phase of growth, bringing together a streamlined executive team from across its commercial businesses, research organisations and global functions. Belén Garijo, CEO at Sanofi, says the refreshed leadership team will help guide the company through its next stage of development while maintaining a strong focus on patients and innovation. "This Executive Committee brings together experienced professionals who will work together to help shape our future direction, make disciplined choices, execute them with focus and ensure we continue to deliver for our patients, our people and all our stakeholders," she says. Belén Garijo, CEO of Sanofi. Credit: Sanofi. A new chapter As of 1 September 2026, Sanofi's Executive Committee will comprise: Paulo Fontoura , Executive Vice President, Head of Research & Development (Formerly Chief Medical Officer at Xaira Therapeutics) Thomas Grenier , Executive Vice President, General Medicines (Formerly Head of North America, Vaccines) François Roger , Executive Vice President, Finance (Formerly Chief Financial Officer) Jamie Haney , Executive Vice President, General Counsel (Formerly Senior Vice President - General Counsel North America & Global Specialty Care) Véronique Jaillet , Executive Vice President, Interim Chief People Officer (Formerly Head of Global Human Resources Manufacturing & Supply) Manuela Buxo , Executive Vice President, Specialty Care Thomas Triomphe , Executive Vice President, Vaccines Brendan O’Callaghan , Executive Vice President, Manufacturing & Supply Paulo Fontoura is a new hire who will join Sanofi on 1 September 2026 from AI-focused biotechnology company Xaira Therapeutics, where he served as Chief Medical Officer. Paulo Fontoura, Executive Vice President, Head of Research & Development. Credit: Xaira Therapeutics. Discussing his new role on LinkedIn, Paulo writes, “I am incredibly excited to be joining Belén Garijo and everyone at team Sanofi in this new role, to work together to create an amazing pipeline of new medicines that will make a real difference in the lives of patients. “I am convinced that we stand at the threshold of a revolution in biopharma R&D, where we can combine our deepening understanding of disease biology with new computational tools in AI/ML to derive new insights that will solve the most complex biology problems and create cures for many more diseases around the world.” New responsibilities for key executives In addition to the refreshed Executive Committee, Sanofi announced that several key figures in its leadership team have taken on new responsibilities as part of the reshuffle. Thomas Triomphe will add responsibility for China alongside his existing role as Executive Vice President of Vaccines , while Olivier Charmeil will step down as Executive Vice President of General Medicines to become Strategic Projects Advisor to CEO Belén Garijo. Madeleine Roach will become President and Country Lead for Germany, Switzerland and Austria, with her Business Operations responsibilities being absorbed into Sanofi's Finance division under François Roger. The expanded finance function will also take responsibility for Global Partnering and Business Development, bringing business development and mergers and acquisitions activities under a single leadership structure. The company says the move is intended to create a more integrated approach to identifying and executing strategic growth opportunities. Maintaining 2026’s momentum The leadership changes follow a busy first half of 2026 for Sanofi, marked by a series of regulatory milestones and pipeline advances. In June, the European Commission approved Sanofi’s Cenrifki medication as the first disability-targeting treatment for secondary progressive multiple sclerosis without relapses, while the company also secured US approval for Tzield as the first disease-modifying therapy for recently diagnosed stage 3 type 1 diabetes. Sanofi has also made strong progress in strengthening its rare disease portfolio in 2026 after receiving US approval for an on-body injector version of its multiple myeloma therapy Sarclisa Escena and reporting positive Phase III results for Nexviazyme in infantile-onset Pompe disease. Company portals Sanofi Executives Belén Garijo Incoming CEO Brendan O'Callaghan Head of Manufacturing and Supply François-Xavier Roger Chief Financial Officer Jamie Haney Senior Vice President - General Counsel North America & Global Specialty Care Madeleine Roach Executive Vice President, Head of Business Operations Manuela Buxo Executive Vice President, Specialty Care Olivier Charmeil Executive Vice President, General Medicines Paulo Fontoura Global Head of Research & Development Pharma Thomas Triomphe Executive Vice President Vaccines, Sanofi Veronique JAILLET Head of Global Human Resources Manufacturing & Supply, Sanofi

Phase 3Executive ChangeDrug ApprovalClinical Result

02 Jul 2026

·pmlive.com

Sanofi announces phase 3 study data for infantile-onset Pompe disease

Sanofi has announced positive results from the Baby-COMET phase 3, single-arm, open-label study, showing that Nexviazyme (avalglucosidase alfa) met its primary endpoint, with a proportion of treatment-naïve infants of six months of age and younger with infantile-onset Pompe disease (IOPD) alive and free of invasive ventilation at 52 weeks of treatment. In addition, the study met all secondary endpoints, including proportion of participants alive and free of invasive ventilation at 12 and 18 months of age, and numerical improvements in other metrics of disease progression at 52 weeks. Pompe disease is a rare, inherited/genetic, progressive neuromuscular disease caused by a deficiency of the acid alpha-glucosidase (GAA) enzyme that affects muscle function throughout the body. IOPD constitutes the most aggressive variant of this disease, manifesting with swift symptom progression during the first months of life. Without therapeutic intervention, IOPD results in severe and potentially fatal complications affecting the heart, breathing and movement. Nexviazyme is being evaluated as a potential treatment option for IOPD, designed to help enter cells and improve uptake of the essential GAA enzyme. This approach may help clear away excess glycogen, which builds up in muscle cells and can cause damage to skeletal and cardiac muscles. Christopher Corsico, Global Head of Development at Sanofi, said: “These positive results offer the potential to expand access of Nexviazyme to more patients and families facing a condition with limited treatment options in the earliest months of life. The Baby-COMET findings are consistent with previous studies and reflect years of our scientific research aimed at translating deep biological understanding into clinical advances for the Pompe community.” Nexviazyme is approved in multiple countries for the treatment of people living with Pompe disease, with specific indications varying by country. In the US, Nexviazyme was approved in 2021 for the treatment of late-onset Pompe disease (LOPD) in patients one year of age and older. In Europe, where the medicine is available under the name Nexviadyme, it received approval for the long-term enzyme replacement therapy of patients with Pompe disease (LOPD and IOPD) in 2022. The results will be shared on 8 July 2026 at the 19th International Congress on Neuromuscular Diseases in Florence, Italy. In addition, the data will support a regulatory submission for a label extension in the US, anticipated in the second half of 2026.

Clinical ResultPhase 3Drug Approval

01 Jul 2026

·www.pharmaceutical-technology.com

Sanofi aims for Nexviazyme approval in younger Pompe disease patients

Sanofi’s Pompe disease drug is already approved in infants after one year and older. Credit: Grand Warszawski / Shutterstock.com Sanofi’s Nexviazyme (avalglucosidase alfa) could be set for approval in younger children with Pompe disease after the Phase III Baby-COMET trial met its primary endpoint. In the single-arm, open-label study (NCT04910776), Nexviazyme met its primary endpoint of the proportion of treatment-naïve paediatric participants six months of age and younger with infantile-onset Pompe disease (IOPD) alive and free of invasive ventilation after 52 weeks of treatment. In addition, the study met all secondary endpoints, including the proportion of participants alive and free of invasive ventilation at 12 and 18 months of age, and numerical improvements in other metrics of disease progression at 52 weeks. In the Baby-COMET study, Nexviazyme was well tolerated, and safety was consistent with its established profile, with no serious treatment-emergent adverse events (TEAEs), deaths, or discontinuations, and manageable infusion-associated reactions in 29.4% of pateints. Nexviazyme is being evaluated as a potential treatment option for IOPD, designed to help enter cells and improve uptake of the essential GAA enzyme. This approach may help clear away excess glycogen, which builds up in muscle cells and can cause damage to skeletal and cardiac muscles. Pompe disease is a rare, inherited/genetic, progressive neuromuscular disease caused by a deficiency of the acid alpha-glucosidase (GAA) enzyme that affects muscle function throughout the body. IOPD constitutes the most aggressive variant of this disease, manifesting with swift symptom progression during the first months of life. Without therapeutic intervention, IOPD results in severe and potentially fatal complications affecting the heart, breathing, and movement. Dr Priya Kishnani, division chief, medical genetics of Duke University Medical Center, said: “IOPD is a devastating, rapidly progressive condition that presents within the first days or weeks of life, making early intervention critical to help improve invasive ventilator-free survival beyond one year. The Baby-COMET study shows the potential of Nexviazyme to support ventilator-free survival in infants, alongside encouraging cardiac and motor outcomes, offering important insights that may help advance the treatment landscape for these patients.” The results will be shared on 8 July 2026 at the 19th International Congress on Neuromuscular Diseases in Florence, Italy. In addition, the data will support a regulatory submission for a label extension in the US, anticipated in the second half of 2026. The drug is already approved in multiple countries for the treatment of people living with Pompe disease, with specific indications varying by country. In the US, Nexviazyme was approved in 2021 for the treatment of late-onset Pompe disease (LOPD) in patients one year of age and older. There are very few drugs approved for use in Pompe Disease. In the US, there are just four drugs on the market, all of which are enzyme replacement therapies (ERTs) or combinations of enzyme therapies with stabiliser. This includes Nexviazyme.

100 Deals associated with Avalglucosidase alfa ngpt

External Link

KEGG	Wiki	ATC	Drug Bank
D11744	Avalglucosidase alfa ngpt	A16AB07	DB16099

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Glycogen Storage Disease Type II	United States	Genzyme Corp.	06 Aug 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02032524 \| NCT01898364 (NEO1/NEO-EXT Studies, AAN2024)	Phase 1/2	Glycogen Storage Disease Type II	24	Avalglucosidase Alfa 5 mg/kg/every other week	dguikknbdm(nyzotiaybm) = nteiseldrm lgevoaoiqo (pdsrbfdlol, 26.0) View more	Positive	09 Apr 2024
				Avalglucosidase Alfa 10 mg/kg/every other week	dguikknbdm(nyzotiaybm) = atjcmpakvz lgevoaoiqo (pdsrbfdlol, 19.3) View more
NCT02032524 (NEO1 and NEO-EXT \| NEO-EXT, CTgov)	Phase 2	Glycogen Storage Disease Type II	19	Avalglucosidase Alfa (Group 1: Avalglucosidase Alfa 5 mg/kg)	jseyvsuodf = aplrpthhat ftvezdclov (hhimnblgni, ignehpieov - diliwqisby) View more	-	01 Mar 2024
				Avalglucosidase Alfa (Group 1: Avalglucosidase Alfa 10 mg/kg)	jseyvsuodf = jhpctvgsif ftvezdclov (hhimnblgni, luskxmhkfh - luplnbfaqm) View more
NCT03019406 (Mini-COMET, SSIEM2023)	Phase 2	Glycogen Storage Disease Type II CK \| Hex4	22	Avalglucosidase alfa 20mg/kg/qow	sxafaginma(fqgpbyyzib) = dttkabolml clkciiooay (kwohzbmskk )	-	30 Aug 2023
				Avalglucosidase alfa 40mg/kg/qow	sxafaginma(fqgpbyyzib) = lirzlukumy clkciiooay (kwohzbmskk )
NCT02782741 (COMET, Pubmed \| JAMA Neurol) Manual	Phase 3	Glycogen Storage Disease Type II First line	100	Avalglucosidase alfa	ehqgcxqbqm(qqtkyjuzun) = izyqegkiqg hntccuhmah (ffzyhgptvu, 1.05) View more	Positive	10 Apr 2023
				Alglucosidase alfa (switched to avalglucosidase alfa after 49 weeks)	ehqgcxqbqm(qqtkyjuzun) = urlngyjaiv hntccuhmah (ffzyhgptvu, 1.12) View more
NCT02782741 (COMET, MDA2023) Manual	Phase 3	Glycogen Storage Disease Type II	100	Avalglucosidase alfa 20 mg/kg (AVAL-arm)	olrpovisle(sqsiwmxnex) = bkhfszinya yzxnnxrkke (cypprskuct, 9.60) View more	Positive	19 Mar 2023
				Alglucosidase alfa 20 mg/kg (Switch-arm)	olrpovisle(sqsiwmxnex) = iuhzgsixtr yzxnnxrkke (cypprskuct, 10.42) View more
NCT03019406 (Mini-COMET, CTgov)	Phase 2	Glycogen Storage Disease Type II	22	Avalglucosidase Alfa (PAP: Cohort 1: Avalglucosidase Alfa 20 mg/kg)	rvbwovhlcx = klkblauqhs ebvtcadilx (szwvjnnbvu, umggdkbszs - ffgypuwrsc) View more	-	22 Nov 2021
				Avalglucosidase Alfa (PAP: Cohort 2: Avalglucosidase Alfa 40 mg/kg)	rvbwovhlcx = mqwfhzoemi ebvtcadilx (szwvjnnbvu, tviiwkitvz - elprzfclfc) View more
NCT02782741 (COMET, EAN2021)	Phase 3	Glycogen Storage Disease Type II	-	Avalglucosidase alfa	obidmniwbb(flvxslpmwy) = aezeyxvzqx jamhnuodgf (wtckprhikt, 9.93)	Positive	18 Jun 2021
				Alglucosidase alfa	obidmniwbb(flvxslpmwy) = atyfpujejd jamhnuodgf (wtckprhikt, 10.40)
NCT02782741 (COMET, CTgov)	Phase 3	Glycogen Storage Disease Type II	101	PAP+Avalglucosidase Alfa (PAP: Avalglucosidase Alfa)	zllbecazsk(egirvnwwgj) = zhfelykzmf rucltuccjs (lgcmdvocrg, 0.88) View more	-	08 Apr 2021
				PAP+Alglucosidase Alfa (PAP: Alglucosidase Alfa)	zllbecazsk(egirvnwwgj) = afutvqtdqb rucltuccjs (lgcmdvocrg, 0.93) View more
NCT01898364 (Pubmed) Manual	Phase 1	Glycogen Storage Disease Type II	24	avalglucosidase alfa (Naïve patients)	cxqvkxikev(dnllrfxpvo) = no deaths/life-threatening serious adverse events (SAEs). dnzajyfyuk (jhxqiujyue ) View more	Positive	01 Mar 2019
				Alglucosidase Alfa (Switch patients)
NCT01898364 (AAN2016)	Phase 1	Glycogen Storage Disease Type II acid α-glucosidase enzyme deficiency	-	neoGAA 5mg/kg	gfiycfnmlg(akjmbeofem) = ugdupamwgc ouhveyvuzt (flxxaiabhg )	-	05 Apr 2016
				neoGAA 10mg/kg	gfiycfnmlg(akjmbeofem) = pfxasmvxjy ouhveyvuzt (flxxaiabhg )

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