Velaglucerase alfa

Velaglucerase alfa, sold under the brand name Vpriv and manufactured by Shire plc, is a hydrolytic lysosomal glucocerebroside-specific enzyme, which is a recombinant form of glucocerebrosidase indicated as a long-term enzyme replacement therapy for those with Gaucher disease Type 1. It has an identical amino acid sequence to the naturally occurring enzyme.[1] It was approved for use by the U.S. Food and Drug Administration (FDA) on February 26, 2010.[2][3]

Velaglucerase alfa
Clinical data
Trade namesVpriv
AHFS/Drugs.comMonograph
License data
Routes of
administration
Intravenous
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • US: ℞-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)
Pharmacokinetic data
BioavailabilityN/A
Elimination half-lifePlasma: 5–12 minutes (absorbed by macrophages)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC2532H3850N672O711S16
Molar mass55593.61 g·mol−1
 NY (what is this?)  (verify)

The most common side effects include abdominal (belly) pain, headache, dizziness, bone pain, arthralgia (joint pain), back pain, infusion-related reactions, asthenia (weakness) or fatigue (tiredness), and pyrexia (fever) or increased body temperature.[4]

Velaglucerase alfa was approved for medical use in the European Union in August 2010.[4]

Medical uses

Velaglucerase alfa is indicated for long-term enzyme-replacement therapy (ERT) in people with type-1 Gaucher disease.[4][5]

Competitive products

Imiglucerase is Genzyme's version of recombinant glucocerebrosidase. It is marketed globally under the trade name of Cerezyme.

In addition, Protalix and Pfizer have received approval for marketing taliglucerase alpha in Israel, Brazil, Canada and the U.S. The companies are expected also to file for marketing authorization in Europe and elsewhere around the world.

References

  1. Burrow TA, Grabowski GA (February 2011). "Velaglucerase alfa in the treatment of Gaucher disease type 1". Clinical Investigation. 1 (2): 285–293. doi:10.4155/cli.10.21. PMC 3172711. PMID 21927713.
  2. "Shire Announces FDA Approval Of VPRIV (velaglucerase Alfa For Injection) For The Treatment Of Type 1 Gaucher Disease". Medical News Today. 27 February 2010.
  3. "Vpriv: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 13 August 2020.
  4. "Vpriv EPAR". European Medicines Agency (EMA). Retrieved 13 August 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. "Vpriv- velaglucerase alfa injection, powder, lyophilized, for solution". DailyMed. 18 June 2020. Retrieved 13 August 2020.


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