Treatment | Lamzede® (velmanase alfa-tycv)

Lamzede^® (velmanase alfa-tycv) is designed to reduce mannose-rich oligosaccharides by supplementing the natural α-mannosidase enzyme¹

Lamzede is an enzyme replacement therapy (ERT) for patients with alpha-mannosidosis—a long-awaited treatment for your patients and their loved ones.¹

Lamzede is a recombinant human α-mannosidase, identical to the naturally occurring enzyme¹

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Without treatment, alpha-mannosidosis causes excess mannose-rich oligosaccharides to build up in the lysosome.²		Lamzede offers an external source to supplement the deficient α-mannosidase enzyme.¹		This weekly treatment helps mitigate excess accumulation and the impact of alpha-mannosidosis over time.¹

Until now, bone marrow transplantation (BMT) was the only option—but its use is often age-restricted, with a median age of 3.6 years²

For more background on Lamzede, review the extensive clinical trial program. Lamzede has been studied in multiple Phase I, II, and III clinical trials, including a long-term trial of patients receiving Lamzede for up to 4 years.^3-11

Overview of Select Clinical Trials
Trial 1 rhLAMAN-05 (N=25): Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy and safety of repeated Lamzede treatment in patients with alpha-mannosidosis.^8,9
Trial 2 rhLAMAN-08 (N=5): 24-month, multicenter, open-label, Phase II trial of the efficacy and safety of repeated Lamzede treatment in patients aged <6 years with alpha-mannosidosis.⁷
Trial 3 Integrated analysis of long-term outcome data that pooled cumulative databases from Phase I, II, and III trials (N=33) for patients aged ≥6 to 35 years.¹⁰
Additional study rhLAMAN-10 (N=18): Single-center, open-label, Phase III clinical trial of the long-term efficacy of Lamzede treatment in patients with alpha-mannosidosis who previously participated in Lamzede trials of up to 4 years.¹¹

Overview of Select Clinical Trials

Trial 1

rhLAMAN-05 (N=25): Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy and safety of repeated Lamzede treatment in patients with alpha-mannosidosis.^8,9

Trial 2

rhLAMAN-08 (N=5): 24-month, multicenter, open-label, Phase II trial of the efficacy and safety of repeated Lamzede treatment in patients aged <6 years with alpha-mannosidosis.⁷

Trial 3

Integrated analysis of long-term outcome data that pooled cumulative databases from Phase I, II, and III trials (N=33) for patients aged ≥6 to 35 years.¹⁰

Additional study

rhLAMAN-10 (N=18): Single-center, open-label, Phase III clinical trial of the long-term efficacy of Lamzede treatment in patients with alpha-mannosidosis who previously participated in Lamzede trials of up to 4 years.¹¹

rhLAMAN, recombinant human α-mannosidase.

1.	Lamzede. Prescribing Information. Chiesi Farmaceutici S.p.A; 2023.
2.	Borgwardt L, Guffon N, Amraoui Y, et al. Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial. J Inherit Metab Dis. 2018;41(6):1215-1223. doi:10.1007/s10545-018-0185-0.
3.	Lund AM, Borgwardt L, Cattaneo F, et al. Comprehensive long-term efficacy and safety of recombinant human alpha-mannosidase (velmanase alfa) treatment in patients with alpha-mannosidosis. J Inherit Metab Dis. 2018;41(6):1225-1233. doi:10.1007/s10545-018-0175-2.
4.	Guffon N, Tylki-Szymanska A, Borgwardt L, et al. Recognition of alpha-mannosidosis in paediatric and adult patients: presentation of a diagnostic algorithm from an international working group. Mol Gen Metab. 2019;126(4):470-474. doi:10.1016/j.ymgme.2019.01.024.
5.	Borgwardt L, Stensland HMFR, Olsen KJ, et al. Alpha-mannosidosis: correlation between phenotype, genotype and mutant MAN2B1 subcellular localisation. Orphanet J Rare Dis. 2015;10:70. doi:10.1186/s13023-015-0286-x.
6.	Beck M, Olsen KJ, Wraith JE, et al. Natural history of alpha mannosidosis a longitudinal study. Orphanet J Rare Dis. 2013;8:88. doi:10.1186/1750-1172-8-88.
7.	Malm D, Nilssen Ø. Alpha-mannosidosis. Orphanet J Rare Dis. 2008;3:21. doi:10.1186/1750-1172-3-21.

1.	Lamzede. Prescribing Information. Chiesi Farmaceutici S.p.A; 2023.
2.	Borgwardt L, Lund AM, Dali CI. Alpha-mannosidosis—a review of genetic, clinical findings and options for treatment. Pediatr Endocrinol Rev. 2014;12(suppl1):185-191.
3.	Borgwardt L, Stensland HMFR, Olsen KJ, et al. Alpha-mannosidosis: correlation between phenotype, genotype and mutant MAN2B1 subcellular localisation. Orphanet J Rare Dis. 2015;10:70. doi:10.1186/s13023-015-0286-x.
4.	Beck M, Olsen KJ, Wraith JE, et al. Natural history of alpha mannosidosis a longitudinal study. Orphanet J Rare Dis. 2013;8:88. doi:10.1186/1750-1172-8-88.
5.	Wiesinger T, Schwarz M, Mechtler TP, et al. α-Mannosidosis—An underdiagnosed lysosomal storage disease in individuals with an ‘MPS-like’ phenotype. Mol Genet Metab. 2020;130(2):149-152. doi:10.1016/j.ymgme.2020.04.001
6.	Malm D, Nilssen Ø. Alpha-mannosidosis. Orphanet J Rare Dis. 2008;3:21. doi:10.1186/1750-1172-3-21.
7.	Guffon N, Tylki-Szymanska A, Borgwardt L, et al. Recognition of alpha-mannosidosis in paediatric and adult patients: presentation of a diagnostic algorithm from an international working group. Mol Gen Metab. 2019;126(4):470-474. doi:10.1016/j.ymgme.2019.01.024.

1.	Lamzede. Prescribing Information. Chiesi Farmaceutici S.p.A; 2023.
2.	Guffon N, Tylki-Szymanska A, Borgwardt L, et al. Recognition of alpha-mannosidosis in paediatric and adult patients: presentation of a diagnostic algorithm from an international working group. Mol Gen Metab. 2019;126(4):470-474. doi:10.1016/j.ymgme.2019.01.024.
3.	Wiesinger T, Schwarz M, Mechtler TP, et al. α-Mannosidosis—An underdiagnosed lysosomal storage disease in individuals with an ‘MPS-like’ phenotype. Mol Genet Metab. 2020;130(2):149-152. doi:10.1016/j.ymgme.2020.04.001
4.	Malm D, Nilssen Ø. Alpha-mannosidosis. Orphanet J Rare Dis. 2008;3:21. doi:10.1186/1750-1172-3-21.

1.	Lamzede. Prescribing Information. Chiesi Farmaceutici S.p.A; 2023.
2.	Borgwardt L, Lund AM, Dali CI. Alpha-mannosidosis – a review of genetic, clinical findings and options for treatment. Pediatr Endocrinol Rev. 2014;12(suppl1):185-191.
3.	The natural history of alpha-mannosidosis (HUE-MAN). ClinicalTrials.gov identifier: NCT00498420. Updated August 3, 2020. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT00498420.
4.	Safety study of recombinant human alpha-mannosidase for the treatment of patients with alpha-mannosidosis. ClinicalTrials.gov identifier: NCT01268358. Updated August 3, 2020. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT01268358.
5.	Dose finding study of recombinant human alpha-mannosidase for the treatment of patients with alpha-mannosidosis. ClinicalTrials.gov identifier: NCT01285700. Updated September 26, 2012. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT01285700.
6.	Long-term efficacy and safety of lamazym for the treatment of patients with alpha-mannosidosis. ClinicalTrials.gov identifier: NCT01681940. Updated March 29, 2017. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT01681940.
7.	Trial on safety and efficacy of velmanase alfa treatment in pediatric patients with alpha-mannosidosis (rhLaman-08). ClinicalTrials.gov identifier: NCT02998879. Updated October 26, 2021. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT02998879.
8.	A placebo-controlled phase 3 trial of repeated lamazym treatment of subjects with alpha-mannosidosis. ClinicalTrials.gov identifier: NCT01681953. Updated August 3, 2020. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT01681953.
9.	Borgwardt L, Guffon N, Amraoui Y, et al. Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial. J Inherit Metab Dis. 2018;41(6):1215-1223. doi: 10.1007/s10545-018-0185-0.
10.	Lund AM, Borgwardt L, Cattaneo F, et al. Comprehensive long-term efficacy and safety of recombinant human alpha-mannosidase (velmanase alfa) treatment in patients with alpha-mannosidosis. J Inherit Metab Dis. 2018;41(6):1225-1233. doi:10.1007/s10545-018-0175-2.
11.	Evaluation of long-term efficacy of treatment with lamazym (rhLAMAN-10). ClinicalTrials.gov identifier: NCT02478840. Updated November 20, 2020. Accessed December 23, 2022. https://clinicaltrials.gov/ct2/show/NCT02478840.

Lamzede, the first and only ERT approved for alpha-mannosidosis1

Lamzede® (velmanase alfa-tycv) is designed to reduce mannose-rich oligosaccharides by supplementing the natural α-mannosidase enzyme1

Lamzede, the first and
only ERT approved for
alpha-mannosidosis¹

Lamzede^® (velmanase alfa-tycv) is designed to reduce mannose-rich oligosaccharides by supplementing the natural α-mannosidase enzyme¹