UCB Gets FDA Approval for Generalized Myasthenia Gravis
June 27, 2023
UCB’s Rystiggo (rozanolixizumab-noli), a treatment for two subtypes of generalized myasthenia gravis (gMG), has been approved by the US Food and Drug Administration (FDA). Muscle weakness episodes in the rare autoimmune disease is caused by antibodies that cling to proteins at the connection site between nerves and muscles. Rystiggo, an antibody-based treatment, reduces circulating antibodies and reduces symptoms.
According to Emily Kimber, “The FDA’s decision was supported by positive results from the phase 3 MycarinG study, in which treatment with Rystiggo resulted in statistically significant improvements at day 43 in gMG-specific outcomes, including everyday activities such as breathing, talking, swallowing, and being able to rise from a chair.”
To read more, click here.
(Source: PM Live, June 27th, 2023)
