Alexion Pharmaceuticals, Inc.

Camille Bedrosian

Leonard Bell

Russell P Rother

Stephen P Squinto

Susan Faas Mcknight

Orly Eshach Adiv

Fanny O'Brien

Jing Jing Wang

Hagit Baris Feldman

Alina Kurolap

The disclosure provides methods of treating myasthenia gravis (MG) in a subject in need thereof by administering to the subject a substance that specifically binds complement component 5 (C5). In certain embodiments, the substance that specifically binds C5 is a binding protein, such as an anti-C5 antibody.

Methods for treatment of refractory generalized myasthenia gravis

Provided are methods for clinical treatment of a protein-losing enteropathy, such as lymphangiectasia, using an anti-C5 antibody, or antigen binding fragment thereof, in patients (e.g., pediatric patients).

Dosage and administration of anti-C5 antibodies for treatment of protein-losing enteropathy in patients

This invention provides, inter alia, a complement-inhibitor-based treatment plan coupled with a risk evaluation and management strategy ('REMS') and a safety support program ('SSP') for reinforcing the REMS. The REMS and SPP are implemented using one or more computer devices with software tools programmed to enforce conditions of the REMS and/or prompt follow-ups by registered nurses enrolled in the SSP. The software tool(s) determines whether a prescriber requesting the complement inhibitor has agreed to abide by the REMS, and can prompt a provider of the complement inhibitor to provide updated educational materials to the prescriber at predetermined times or intervals, to monitor the prescriber for compliance with the REMS, and/or to monitor patients for signs of adverse events. Using exemplary embodiments described herein, a risk of adverse events (especially, but not limited to, meningococcal infections) can be managed and an incidence of the adverse events can be reduced.

Risk evaluation and management strategy involving patient follow-ups relating to the use or discontinuation of a complement inhibitor

The present disclosure relates to, inter alia, compositions containing an inhibitor of human complement and use of the compositions in methods for treating or preventing complement-associated disorders. In some embodiments, the inhibitor is chronically administered to patients. In some embodiments, the inhibitor is administered to a patient in an amount and with a frequency to maintain systemic complement inhibition and prevent breakthrough. In some embodiments, the compositions contain an antibody, or antigen-binding fragment thereof, that binds to a human complement component C5 protein or a fragment of the protein such as C5a or C5b.

Methods for treating complement-associated disorders

Methods and compositions for treating complement-associated disorders

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Woodbridge, CT, United States of America

Camille Bedrosian