Vyvgart

efgartigimod alfa

Table of contents

Opinion

On 23 June 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Vyvgart1, intended for the treatment of anti‑acetylcholine receptor (AChR) antibody positive generalised Myasthenia Gravis. The applicant for this medicinal product is Argenx.

Vyvgart will be available as 20mg/ml concentrate for solution for infusion. The active substance of Vyvgart is efgartigimod alfa, an immunosuppressant (ATC code: L04AA58). Efgartigimod alfa is a fragment of human IgG1 antibody that binds to the neonatal Fc Receptor (FcRn), thereby decreasing the levels of circulating IgG, including pathogenic IgG autoantibodies.

Benefits of Vyvgart include a decrease in functional disability as rated by patients, and less disease severity as assessed by qualified physicians, as compared with placebo in clinical trials. The most common side effects are upper respiratory tract infections and urinary tract infections.

The full indication is:

Vyvgart is indicated 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.

Efgartigimod alfa must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with neuromuscular disorders.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


1 This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

Key facts

Name
Vyvgart
Agency product number
EMEA/H/C/005849
International non-proprietary name (INN) or common name
  • efgartigimod alfa
Active substance
  • Efgartigimod alfa
Therapeutic area
Myasthenia Gravis
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
23/06/2022
Company name
Argenx
Status
Positive
Application type
Initial authorisation

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