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Last Updated: March 28, 2024

Patent: 8,871,449


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Summary for Patent: 8,871,449
Title:Methods and products for evaluating an immune response to a therapeutic protein
Abstract: The invention relates to methods and products for the identification of a clinically significant immune response in subjects treated with a therapeutic protein. Aspects of the invention relate to methods and compositions for identifying a clinically significant immune response in patients treated with therapeutic amounts of a VLA4 binding antibody (e.g., natalizumab). A second aspect of the invention concerns the chronological details of sample collection for determining the titre of antibodies against the therapeutic protein, e.g. the collection of at least two samples at two different time points. A third aspect of the invention relates to the selection of the critical threshold level, which corresponds to the antibody titre of untreated patients increased by the double of the standard deviation of this control antibody titre.
Inventor(s): Subramanyam; Meena (Stoneham, MA), Amaravadi; Lakshmi (Natick, MA), Wakshull; Eric (Princeton, MA), Lynn; Frances (Somerville, MA), Panzara; Michael (Winchester, MA), Barbour; Robin McDaid (Walnut Creek, CA), Taylor; Julie Elizabeth (San Francisco, CA)
Assignee: Biogen Idec MA Inc. (Cambridge, MA)
Application Number:13/242,505
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,871,449
Patent Claims:see list of patent claims

Details for Patent 8,871,449

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Biogen Inc. TYSABRI natalizumab Injection 125104 11/23/2004 ⤷  Try a Trial 2025-04-04
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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