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Generated: August 21, 2019

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Patent: 9,709,575

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Summary for Patent: 9,709,575
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. A first aspect of the invention relates to methods and compositions for identifying a clinically significant immune response in patients treated with therapeutic amounts of VLA4 binding antibody (e.g., natalizumab). A second aspect of the invention concerns the chronological details of sample collection for determining the titer 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 titer of untreated patients increased by the double of the standard deviation of this control antibody titer.
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 MA Inc. (Cambridge, MA)
Application Number:14/330,619
Patent Claims:see list of patent claims

Details for Patent 9,709,575

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Biogen Idec TYSABRI natalizumab VIAL; SINGLE-USE 125104 001 2004-11-23   Try a Free Trial Biogen MA Inc. (Cambridge, MA) 2025-04-04 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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