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    Taliglucerase alfa

    From Mdwiki - Reading time: 6 min
    Taliglucerase alfa
    Names
    Trade namesElelyso, Uplyso, others
    Clinical data
    Drug classEnzyme[1]
    Main usesGaucher's disease[1]
    Side effectsHeadache, joint pain, tiredness, nausea, itchiness, rash[1]
    Pregnancy
    category
    • AU: B1
    • US: N (Not classified yet)
    Routes of
    use    		Intravenous infusion
    Typical dose60 units/kg[1]
    External links
    AHFS/Drugs.comMonograph
    Legal
    Legal status
    • US: ℞-only
    • In general: ℞ (Prescription only)
    Pharmacokinetics
    Elimination half-life18.9-28.7 minutes
    Chemical and physical data
    FormulaC2580H3918N680O727S17
    Molar mass56638.78 g·mol−1

    Taliglucerase alfa, sold under the brand name Elelyso among others, is a medication used to treat Gaucher's disease type I.[1] It is given by gradual injection into a vein.[1] It is used long term.[1]

    Common side effects include headache, joint pain, tiredness, nausea, itchiness, and rash.[1] Other side effects may include anaphylaxis.[1] It is a glucocerebrosidase made by recombinant DNA technology and works by replacing this missing enzyme.[1]

    Taliglucerase alfa was approved for medical use in the United States in 2012.[1] In Europe it received an orphan designation in 2010 but was declined approval in 2012 due to the similar product velaglucerase alfa having market exclusivity.[2] In the United States it costs about 18,000 USD per dose for a 70 kg person (465,000 USD per year).[3] It is the first plant-made medication to be approved in the United States.[4][5]

    Medical uses[edit | edit source]

    Dosage[edit | edit source]

    It is given at a dose of 60 units per kg every two weeks.[1] The typical dose for a 70 kg person is thus 4,200 units.

    Each vial has 200 units of taliglucerase alfa.

    History[edit | edit source]

    The U.S. FDA New Drug Application (NDA) was granted approval in May 2012, for use in adults.[6][7] The U.S. FDA Supplemental New Drug Application (sNDA) for pediatric use was granted approved in August 2014.[8] In Israel, the Israeli Ministry of Health granted approval in September 2012.[9] In Brazil, the Brazilian Health Surveillance Agency (ANVISA) granted approval in March 2013. In Canada, Health Canada issued a Notice of Compliance in May 2014, for both adults and pediatric patients.[10]

    Taliglucerase alfa is made by the Israeli biotherapeutics company Protalix and sold by the American pharmaceutical company Pfizer.[citation needed]

    Society and culture[edit | edit source]

    Economics[edit | edit source]

    For 2016, Elelyso was ranked third for pharmaceuticals with the highest cost-per-patient, with an average cost of $483,242 per year.[11]

    References[edit | edit source]

    1. ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 "Taliglucerase Alfa Monograph for Professionals". Drugs.com. Archived from the original on 16 July 2017. Retrieved 21 September 2021.
    2. ↑ "Elelyso". Archived from the original on 29 August 2021. Retrieved 21 September 2021.
    3. ↑ "Elelyso Prices, Coupons & Patient Assistance Programs". Drugs.com. Archived from the original on 26 January 2021. Retrieved 21 September 2021.
    4. ↑ Kaiser J (April 2008). "Is the drought over for pharming?". Science. 320 (5875): 473–5. doi:10.1126/science.320.5875.473. PMID 18436771. S2CID 28407422.
    5. ↑ Maxmen A (2 May 2012). "First plant-made drug on the market". Nature, Biology & Biotechnology, Industry. Archived from the original on 18 October 2012. Retrieved 26 June 2012.
    6. ↑ Beitz J. "Elenyso (taliglucerase alfa) NDA Approval" (PDF). Center for Drug Evaluation and Research. U.S. Food and Drug Administration. Archived (PDF) from the original on 2021-04-01. Retrieved 2020-11-05.
    7. ↑ "Elenyso (taliglucerase alfa): Highlights of Prescribing Information" (PDF). U.S. Food and Drug Administration. Archived (PDF) from the original on 2021-04-01. Retrieved 2020-11-05.
    8. ↑ "Supplement Approval Fulfillment of Postmarketing Requirement" (PDF). U.S. Food and Drug Administration. Archived (PDF) from the original on 2021-04-02. Retrieved 2020-11-05.
    9. ↑ "מאגר התרופות (Drug details for Elelyso)". Ministry of Health Israel. Archived from the original on 2017-09-08. Retrieved 2020-11-05.
    10. ↑ "Summary Basis of Decision (SBD): Elelyso". Health Canada. 2014-08-01. Archived from the original on 2014-08-06.
    11. ↑ "Medical Pharmacy Trend Report" (PDF). Magellan Rx Management (seventh ed.). 2016. Archived from the original (PDF) on 29 March 2019.

    External links[edit | edit source]

    Identifiers:
    • "Taliglucerase alfa". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2021-08-29. Retrieved 2020-11-05.
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