European Commission Grants Approval to Amgen's UPLIZNA® for Treating Generalized Myasthenia Gravis
Amgen's UPLIZNA® Gains European Approval for Myasthenia Gravis
Amgen (NASDAQ: AMGN) announced that the European Commission has granted approval for UPLIZNA® (inebilizumab) as a supplemental treatment for adults diagnosed with generalized myasthenia gravis (gMG) who are positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibodies. This significant development offers patients a new option, aiming for long-term disease management with biannual dosing after two initial administration doses.
Understanding Myasthenia Gravis
Generalized myasthenia gravis is a rare, chronic autoimmune condition characterized by fluctuating muscle weakness that can dramatically affect daily life and overall quality of life. It primarily impacts individuals by disrupting neuromuscular communication, leading to muscular fatigue, difficulty in swallowing, and issues concerning vision and breathing. More than 56,000 to 123,000 people across Europe are affected by this condition, with the prevalence and incidence on the rise globally.
A New Hope for Patients
Cesar Sanz Rodriguez, Vice President of Medical Affairs at Amgen, highlighted the importance of this approval.