Claims for Patent: 11,244,744
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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 | ⤷ Try for Free | 2037-06-06 |
Wyeth Pharmaceuticals Llc | TRUMENBA | meningococcal group b vaccine | Injection | 125549 | October 29, 2014 | ⤷ Try for Free | 2037-06-06 |
>Applicant | >Tradename | >Biologic Ingredient | >Dosage Form | >BLA | >Approval Date | >Patent No. | >Expiredate |