Express is expected to come out early next year, and myasthenia gravis therapy has been prioritized by the FDA

argenx today announced that the U.
S.
Food and Drug Administration (FDA) has accepted its efgartigimod subcutaneous injection formulation for the treatment of adult patients with generalized myasthenia gravis (gMG) and granted priority review status
.
FDA expects to complete its review
on March 20, 2023.

Myasthenia gravis is a rare chronic autoimmune disease
.
IgG antibodies in patients disrupt communication between nerves and muscles, causing weakness and potentially life-threatening muscle weakness
.
More than 85% of patients progress to generalized myasthenia gravis within 18 months of onset, resulting in extreme fatigue and difficulty
with facial expression, speech, swallowing, and movement.

Efgartigimod is a "first-in-class" therapy
that targets the Fc receptor (FcRn).
Its intravenous infusion (IV) formulation, Vyvgargimod alfa-fcab, was approved last December, becoming the first FDA-approved FcRn blocker
.
Efgartigimod reduces pathogenic IgG antibodies and blocks the IgG recycling process
.
The role of the FcRn receptor is to prevent the degradation of IgG, so by preventing the binding of IgG to FcRn, it can lead to faster depletion of IgG antibodies mediating autoimmune diseases, thereby reducing disease symptoms
.
Zai Lab has partnered with ArgenX to acquire the rights
to develop and commercialize this innovative therapy in Greater China.

The Efgartigimod subcutaneous injection preparation contains recombinant human hyaluronidase PH20 (rHuPH20).

Developed by Halozyme Therapeutics, rHuPH20 can degrade hyaluronic acid in the body to aid penetration and absorption of subcutaneous injection drugs, providing patients with additional treatment options
.

▲Argenx R&D pipeline (Image source: Argenx official website)

The submission is based on the results of
the ADAPT-SC Phase 3 trial.
The trial evaluated the pharmacodynamic effects
of efgartigimod subcutaneous formulations compared to intravenous infusion preparations in 110 adult patients with gMG.
The trial met the primary endpoint of non-inferiority criteria (p<0.
0001), with a 66.
4% reduction in mean total IgG levels at day 29 compared with 62.
2%
in the intravenous formulation group.
In addition, the trial met other key secondary endpoints consistent with the clinical efficacy outcomes observed in the Phase 3 clinical trial of intravenous infusion formulations, including improvements
in scores such as myasthenia gravis activities of daily living (MG-ADL) and quantitative myasthenia gravis (QMG).
Its safety profile is also consistent with previous studies and is generally well tolerated, with the most common adverse event being injection site reaction (ISR).

"The FDA's acceptance of our BLA is an important step
in completing our expansion of gMG patient therapies to assist every patient experiencing this debilitating disease.
We are excited about the opportunity for gMG patients to receive different doses in multiple ways," said Mr.
Keith Woods, Chief Operating Officer of argenx, "With the exact PDUFA date, we are preparing to launch our second commercial product and we look forward to the opportunity to launch another treatment option
for gMG patients.
" ”

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