Efgartigimodalfa (generalized myasthenia gravis) ' Benefit assessment according to '35a Social Code Book V 1 Translation of Sections I 1 to I 5 of the dossier assessment Efgartigimodalfa ( generalisierte Myasthenia gravis) – Nutzenbewertung gemäß § 35a SGB V. Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Efgartigimodalfa (generalized myasthenia gravis) Benefit assessment according to §35a SGB V1 EXTRACT Project: A24-36 Version: 1.0 Status: 25 Jun 2024 DOI: 10.60584/A24-36_en Extract of dossier assessment A24-36 Version 1.0 Efgartigimodalfa ( generalized myasthenia gravis) 25 Jun 2024 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing
EfgartigimodAlfa (Vyvgart) - myasthenia gravis View of EfgartigimodAlfa (Vyvgart) | Canadian Journal of Health TechnologiesReturn to Article DetailsEfgartigimod Alfa (Vyvgart)
EfgartigimodAlfa (Vyvgart) - Generalized myasthenia gravis View of EfgartigimodAlfa (Vyvgart) | Canadian Journal of Health TechnologiesReturn to Article DetailsEfgartigimod Alfa (Vyvgart)
Summary of COHERE Finland's recommendation on efgartigimodalfa for treating myasthenia gravis Summary 1(2) 14.9.2023 STM023:00/2023 VN/1238/2023 PO BOX 33 (Meritullinkatu 8, Helsinki) 00023 GOVERNMENT, Finland Tel 358 295 16001 www.palveluvalikoima.fi e-mail: palveluvalikoima.stm@gov.fi RECOMMENDATION ON EFGARTIGIMODALFA FOR TREATING MYASTHENIA GRAVIS At its meeting of 14 September 2023, the Council for Choices in Health Care in Finland (COHERE Finland) adopted a recommendation on efgartigimodalfa in the treatment of myasthenia gravis. Efgartigimodalfa is not included in the national range of services for treating generalised myasthenia gravis. Responses to treatment were short-lived, and so far there is only short-term research data available. The clinical relevance
Efgartigimodalfa (Vyvgart) - generalised Myasthenia Gravis (gMG) 1 Published 13 November 2023 1 SMC2561 efgartigimodalfa concentrate for solution for infusion (Vyvgart®) Argenx 06 October 2023 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland . The advice is summarised as follows: ADVICE: following a full submission assessed the under orphan medicine process efgartigimodalfa (Vyvgart®) is not recommended for use within NHSScotland. Indication under review: as an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. In a phase III
EfgartigimodAlfa in Generalised Myasthenia Gravis: A Profile of Its Use. Intravenous efgartigimodalfa (also known as efgartigimodalfa-fcab in the USA; Vyvgart) is the first neonatal Fc receptor antagonist approved in several countries worldwide, including the USA and EU for the treatment of generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive, and in Japan for the treatment of gMG regardless of antibody status. In the double-blind, placebo-controlled phase 3 ADAPT trial in patients with gMG, efgartigimodalfa significantly and rapidly reduced disease burden and improved muscle strength and quality of life compared with placebo. The clinical benefits of efgartigimodalfa were durable and reproducible. Furthermore, in an interim
EfgartigimodAlfa An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM Levels and EffectsSummary of Use during LactationNo information is available on the clinical use of efgartigimodalfa during breastfeeding. Because efgartigimodalfa is a large protein molecule with a molecular weight of 54,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably
A Non-interventional, Post-authorisation Safety Study of Patients Treated With EfgartigimodAlfa This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who
gravis for whom add-on therapy to standard treatment is an option Eculizumab (for refractory patients) or efgartigimodalfa or ravulizumabb, c a. Presented is the ACT specified by the G-BA. b. In accordance with the G-BA, it is assumed that patients in both study arms receive guideline-compliant therapy with cholinesterase inhibitors as well as basic immunosuppressive therapy, if indicated. It is also ; G-BA: Federal Joint Committee In the dossier, the company states that it follows the G-BA's definition of the ACT and names eculizumab (for refractory patients) or efgartigimodalfa or ravulizumab as the ACT. In its assessment, however, the company includes studies versus any comparator therapy and bases its assessment primarily on placebo-controlled studies. The approach of the company
the anticholinesterase inhibitor pyridostigmine and immunotherapy (a corticosteroid or other immunosuppressant). Thymectomy is required if thymoma is present. Thymectomy has also been shown to be effective in people with generalised MG without thymoma who are AChR antibody positive.Newer therapies for patients with generalised MG with AChR antibodies include eculizumab, efgartigimodalfa, and ravulizumab.Approximately
on nivolumab in combination with relatlimab for the first-line treatment of advanced cutaneous melanoma 14.9.2023 Summary of COHERE Finland's recommendation on efgartigimodalfa for treating myasthenia gravis 15.6.2023 Summary of COHERE Finland's recommendation on the gognitive rehabilitation of people with psychotic disorders in the schizophrenia spectrum 4.5.2023 Summary of COHERE Finland’s recommendation
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