The US Food and Drug Administration (FDA) has approved a pre-filled syringe version of argenx’s Vyvgart, giving generalised myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) patients the option to self-inject the immune disorder drug at home.
The Vyvgart Hytrulo prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc), co-formulated with Halozyme’s ENHANZE drug delivery technology, has been approved as a 20-to-30-second subcutaneous injection to be administered by patients, caregivers or healthcare professionals.
gMG occurs when IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Patients with confirmed anti-AChR antibodies, the population for which Vyvgart is approved, account for approximately 85% of the total gMG population.
There is also increasing evidence that IgG antibodies play a key role in CIDP, which affects the peripheral nervous system and results in fatigue, muscle weakness and loss of feeling in the arms and legs.
Vyvgart is a human IgG1 antibody fragment that binds to the neonatal Fc receptor, resulting in the reduction of circulating IgG autoantibodies. The drug now offers three administration options, following approvals of the drug as an intravenous infusion (Vyvgart) and subcutaneous injection (Halozyme-partnered Vyvgart Hytrulo).
It is hoped that the self-injection administration option will improve disease management by giving patients the flexibility to decide when and where they receive treatment, and reducing the time required for treatment.
The FDA’s latest approval of the therapy was based on data from studies evaluating the pre-filled syringe version’s bioequivalence to Vyvgart Hytrulo in a vial.
Also supporting the decision were results from human factors validation studies, which demonstrated that patients, or their caregivers, safely and successfully administered Vyvgar Hytrulo with the pre-filled syringe.
Luc Truyen, argenx’s chief medical officer, said: “We understand patients experience [gMG] and CIDP in different ways, and our pre-filled syringe is an important innovation that provides patients with more freedom and flexibility to self-administer Vyvgart Hytrulo.
“Whether patients prefer to receive their treatment in a physician’s office, at home or while traveling, they can experience treatment on their own terms and continue to benefit from Vyvgart Hytrulo’s favourable safety profile and strong efficacy.”
