Claims for Patent: 11,244,744

Summary for Patent: 11,244,744

Title:	Risk evaluation and management strategy involving patient follow-ups relating to the use or discontinuation of a complement inhibitor
Abstract:	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.
Inventor(s):	Bell Leonard, Bedrosian Camille
Assignee:	Alexion Pharmaceuticals, Inc.
Application Number:	US15614964
Patent Claims:

Details for Patent 11,244,744

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Glaxosmithkline Biologicals	BEXSERO	meningococcal group b vaccine	Injection	125546	January 23, 2015	11,244,744	2037-06-06
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549	October 29, 2014	11,244,744	2037-06-06