Drugs / Velmanase Alfa
Velmanase Alfa
also known as
Lamazym · A16AB · CHF-LMZYMAA1 · Lamzede · R-h-laman · Recombinant Human Alpha-mannosidase · Recombinant human laman · Velmanasa alfa · +1 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Lamzede | — | 2018-03-23 | europa.eu ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01268358 | Oct 2010 → Jan 2011 | alpha-mannosidosis | Zymenex A/S | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT02998879 | Dec 2016 → Jul 2020 | alpha-mannosidosis | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT01681940 | Jan → Aug 2012 | alpha-mannosidosis | Zymenex A/S | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT04031066 | Jan → Oct 2021 | alpha-mannosidosis | Chiesi Farmaceutici S.p.A. | Withdrawn | No outcome recorded |
| Phase 3 | NCT02478840 | Feb → Jun 2015 | alpha-mannosidosis | Zymenex A/S | Completed | No outcome recorded |
| Phase 3 | NCT01908712 | Aug 2013 → Sep 2022 | alpha-mannosidosis | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT01908725 | Jun 2013 → Sep 2022 | alpha-mannosidosis | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04959240 | — | alpha-mannosidosis | Chiesi Farmaceutici S.p.A. | Available | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT01285700 Comparator | Jan 2011 → Jan 2012 | alpha-mannosidosis | Zymenex A/S | Unknown | No outcome recorded |
| Phase 3 | NCT01681953 Comparator | Aug 2012 → May 2014 | alpha-mannosidosis | Zymenex A/S | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2023-02-24 | Chiesi Farmaceutici S.p.A. | Results Chiesi Global Rare Diseases Presents Long-Term Results from Phase 3 BALANCE and BRIGHT Studies in Fabry Disease at the 19th Annual WORLDSymposium™ Research Meeting chiesi.com ↗
Company also presents insights from the SPARKLE registry in alpha-mannosidosis that highlight a delay in diagnosis, identify the most frequent genetic MAN2B1 variant in enrolled participants, and report on real-world clinical profiles. |
| 2023-02-22 | Chiesi Farmaceutici S.p.A. | Regulatory Chiesi Global Rare Diseases Announces FDA Approval of Lamzede® (velmanase alfa-tycv) for Alpha-Mannosidosis chiesi.com ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-02-24 | Chiesi Farmaceutici S.p.A. | Chiesi Global Rare Diseases Presents Long-Term Results from Phase 3 BALANCE and BRIGHT Studies in Fabry Disease at the 19th Annual WORLDSymposium™ Research Meeting chiesi.com ↗ |
| 2023-02-22 | Chiesi Farmaceutici S.p.A. | Chiesi Global Rare Diseases Announces FDA Approval of Lamzede® (velmanase alfa-tycv) for Alpha-Mannosidosis chiesi.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | velmanase alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04031066 ↗ |
| Known as | A16AB | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298010 ↗ |
| Known as | CHF-LMZYMAA1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298010 ↗ |
| Known as | Lamazym | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01681940 ↗ |
| Known as | Lamzede | “The overall objective of this trial is to provide aftercare treatment with Lamazym and to evaluate the safety of repeated Lamzede i.v. treatment of subjects with alpha-Mannosidosis.” NCT01908712 ↗ |
| Known as | R-h-laman | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298010 ↗ |
| Known as | Recombinant Human Alpha-mannosidase | “A Single Center, Open-label, Dose Escalation Study of the Safety and Pharmacokinetics of rhLAMAN (Recombinant Human Alpha-mannosidase or Lamazym) for the Treatment of Patients...” NCT01268358 ↗ |
| Known as | Recombinant human laman | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298010 ↗ |
| Known as | Velmanasa alfa | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298010 ↗ |
| Known as | Velmanase alfa-tycv | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298010 ↗ |
| Modality | Protein / enzyme biologic | “A recombinant human alpha-mannosidase (rhLAMAN) has been developed for weekly intravenous enzyme replacement therapy (ERT).” PMID 23494656 ↗ Mar 2013 |
| Route | Intravenous | “receiving intravenous infusions of Lamazym” NCT01268358 ↗ |