The U.S. Food and Drug Administration (FDA) has approved VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
CIDP is a rare neurological disorder that causes progressive weakness and impaired sensory function in the legs and arms. CIPD is characterized by an immune response that leads to inflammation of peripheral nerves and demyelination. . Symptoms often include tingling or numbness (first in the toes and fingers), weakness of the arms and legs, loss of deep tendon reflexes, fatigue, and abnormal sensations. Other symptoms may include pain, difficulty swallowing, and double vision. CIDP is thought to be caused by the immune system mistakenly attacking and damaging the myelin sheath of the peripheral nerves. CIDP is closely related to Guillain-Barre syndrome (GBS) and is considered the “chronic counterpart” of GBS.
Treating patients with CIPD is largely focused on replacing the immunoglobulin G (IgG) that is attacking the nerves with healthy IgG (i.e., via intravenous IgG, plasma exchange). Efgartigimod offers a more targeted approach to reduce circulating levels of pathologic IgG in the body.
Efgartigimod alfa and hyaluronidase-qvfc is the first neonatal Fc receptor (FcRn) blocker approved for CIDP, administered as a once-weekly subcutaneous injection. FcRn naturally preserves the cellular levels of IgG and increased levels of IgG are associated with CIPD. By blocking FcRn, efgartigimod reduces circulating IgG.
The approval follows results from the ADHERE clinical study where the treatment met its primary endpoint with a 61% reduction in the risk of relapse versus placebo. Additionally, 69% of patients demonstrated clinical improvement in mobility, function, and strength, as well as evidence of safety.
To learn more, visit https://www.argenx.com/news/argenx-announces-fda-approval-vyvgart-hytrulo-chronic-inflammatory-demyelinating-polyneuropathy
For more information on rare neurological diseases, visit https://checkrare.com/diseases/neurology-nervous-system-diseases/
Tags: Neuro, musculoskeletal, autoimmune, treatment, regulations,