This Drug Was Just Recommended for Approval for Myasthenia Gravis in the EU

According to a story from Myasthenia Gravis News, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has recommended ravulizumab (marketed as Ultomiris) to be approved as an add-on therapy for adult patients living with generalized myasthenia gravis that are positive for the AChR antibody. This is the most common form of the disease, covering around 80 percent of patients.

About Myasthenia Gravis

Myasthenia gravis is a long term autoimmune disease that is most characterized by weakness of the skeletal muscles which can affect a patient’s ability to move and breathe. As an autoimmune disease, it is ultimately the result of abnormal immune system behavior in which the system attacks normal body tissue. In this disease, the immune system produces antibodies that inhibit regular neuromuscular function. Symptoms of the illness include muscle weakness that worsens after activity and gets better after resting. This weakness may affect the face, eyes, neck, breathing, and limbs. It may cause speech and swallowing difficulties, eyelid drooping, shortness of breath, and blurred vision. In severe cases, patients may require breathing assistance with a ventilator. Treatment options include immunosuppressive medications, thymus gland removal, IVIG, and plasmapharesis. Most patients can effectively manage the condition with treatment. To learn more about myasthenia gravis, click here.

About Ultomiris

The final approval of this medication will fall on the European Commission, which will review recommendations from CHMP. Ultomiris was originally developed by Alexion Pharmaceuticals and follows another myasthenia gravis medicine developed by the company called Soliris. Ultomiris offers the advantage of less frequent doses following an initial loading period. 

The recommendation follows the approval of Ultomiris for myasthenia gravis in the US back in April, and the therapy is also under review in several other countries as well. The therapy performed well in a phase 3 clinical trial of 175 adult patients, demonstrating superior reduction of symptom severity in comparison to placebo, and also improve fatigue and quality of life; benefits became evident after just one week of treatment in some patients.

Ultomiris also has prior approvals for two other autoimmune disorders, including paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome

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