MHRA approves argenx’s subcutaneous generalised myasthenia gravis therapy
Drug Approval
Preview
Source: PMLiVE
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised a new subcutaneous (SC) formulation of argenx’s Vyvgart (efgartigimod alfa) for generalised myasthenia gravis (gMG).
The regulator has specifically licensed the SC injectable version of the FcRn blocker, co-formulated with Halozyme’s proprietary recombinant human hyaluronidase technology, for use as an add-on to standard therapy for adult gMG patients who are anti-acetylcholine receptor (AChR) antibody positive.
Vyvgart is now authorised in the UK for both intravenous (IV) and SC use, including possible SC self-administration.
The MHRA’s latest decision is supported by positive results from the late-stage ADAPT-SC study, in which SC Vyvgart was found to be as effective as the IV version at reducing anti-AChR antibody levels.
gMG is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness.
Patients with confirmed anti-AChR antibodies account for approximately 85% of the total gMG population.
"Our focus now will be on ensuring seamless access to this medicine for all those who could potentially benefit, and we are working closely with authorities across the UK to make this a reality,” Knechtel added.
SC Vyvgart was approved by the European Commission and US Food and Drug Administration for the same gMG population in November and June 2023.
Commenting on the latest authorisation, Sivakumar Sathasivam, consultant neurologist and myasthenia gravis lead at the Walton Centre, said: “There is a clear unmet need for an effective therapy that can be used to manage gMG patients whose symptoms remain significantly uncontrolled despite established clinical management.
“SC [Vyvgart] provides a new and easier-to-administer treatment option for these people, with the ability to potentially impact their quality of life and disease burden.’’
Beyond gMG, argenx said it is also evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier-stage experimental medicines.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Targets
-Drugs
Chat with Hiro
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.