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Last Updated: March 29, 2024

Claims for Patent: 10,485,797


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Summary for Patent: 10,485,797
Title:Treatment of pemphigus
Abstract: The present disclosure provides methods of treating with a BTK inhibitor a blistering disease, in particular pemphigus vulgaris or pemphigus folliaceous in a mammal, use of a BTK inhibitor as a replacement therapy for corticosteroid therapy for diseases treatable with a corticosteroid, such as autoimmune or inflammatory disease and in particular where corticosteroids are used as first or second line therapy, and pharmaceutical formulations comprising the same.
Inventor(s): Gourlay; Steven (San Francisco, CA)
Assignee: PRINCIPIA BIOPHARMA INC. (South San Francisco, CA)
Application Number:15/537,294
Patent Claims:1. A method of treating pemphigus vulgaris or pemphigus foliaceus in a human in need thereof, said method comprising administering to said human a therapeutically effective amount of a BTK inhibitor (R,E)-2-(3-(4-amino-3-(2-fluoro-4-phenoxyphenyl)-1H-pyrazolo[3,4-d]-pyrim- idin-1-yl)piperidine-1-carbonyl)-4,4-dimethylpent-2-enenitrile.

2. The method of claim 1, wherein said BTK inhibitor is used in place of a corticosteroid therapy.

3. The method of claim 1, wherein said BTK inhibitor is used in combination with a corticosteroid therapy.

4. The method of claim 1, further comprising administering said BTK inhibitor in combination with a noncorticosteroidal immunosupressive and/or anti-inflammatory agent.

5. The method of claim 1, wherein said noncorticosteroidal immunosuppressive and/or anti-inflammatory agent is chosen from anti-CD20 antibody, anti-TNF antibody, anti-IL6 agent, anti-IL17 agent, and abatacept.

6. The method of claim 4, wherein said noncorticosteroidal immunosuppressive and/or anti-inflammatory agent is chosen from rituximab, tositumomab, veltuzumab, obinutuzumab, Enbrel, and ofatumumab, or a biosimilar version thereof.

7. A method of eliminating or reducing a therapeutic dose of a corticosteroid therapy used in the treatment of pemphigus vulgaris or pemphigus foliaceus in a human in need thereof, wherein said corticosteroid therapy is used as the first or second line in chronic maintenance therapy, said method comprising administering to said human a therapeutically effective amount of a BTK inhibitor (R,E)-2-(3-(4-amino-3-(2-fluoro-4-phenoxyphenyl)-1H-pyrazolo[3,4-d]-pyrim- idin-1-yl)piperidine-1-carbonyl)-4,4-dimethylpent-2-enenitrile.

8. The method of claim 7, wherein said BTK inhibitor is used in place of said corticosteroid therapy.

9. The method of claim 7, wherein said BTK inhibitor is used in combination with said corticosteroid therapy.

10. The method of claim 7, further comprising administering said BTK inhibitor in combination with a noncorticosteroidal immunosupressive and/or anti-inflammatory agent.

11. The method of claim 10, wherein said noncorticosteroidal immunosuppressive and/or anti-inflammatory agent is chosen from anti-CD20 antibody, anti-TNF antibody, anti-IL6 agent, anti-IL17 agent, and abatacept.

12. The method of claim 10, wherein said noncorticosteroidal immunosuppressive and/or anti-inflammatory agent is chosen from rituximab, tositumomab, veltuzumab, obinutuzumab, Enbrel, and ofatumumab, or a biosimilar version thereof.

13. A method of treating acute flares of pemphigus vulgaris or pemphigus foliaceous in a human in need thereof, wherein a corticosteroid therapy is used as the first or second line in chronic maintenance therapy, comprising administering to said human a therapeutically effective amount of a BTK inhibitor (R,E)-2-(3-(4-amino-3-(2-fluoro-4-phenoxyphenyl)-1H-pyrazolo[3,4-d]-pyrim- idin-1-yl)piperidine-1-carbonyl)-4,4-dimethylpent-2-enenitrile.

14. The method of claim 13, wherein said BTK inhibitor is used in place of said corticosteroid therapy.

15. The method of claim 13, wherein said BTK inhibitor is used in combination with said corticosteroid therapy.

16. The method of claim 13, further comprising administering said BTK inhibitor in combination with a noncorticosteroidal immunosupressive and/or anti-inflammatory agent.

17. The method of claim 16, wherein said noncorticosteroidal immunosuppressive and/or anti-inflammatory agent is chosen from anti-CD20 antibody, anti-TNF antibody, anti-IL6 agent, anti-IL17 agent, and abatacept.

18. The method of claim 16, wherein said noncorticosteroidal immunosuppressive and/or anti-inflammatory agent is chosen from rituximab, tositumomab, veltuzumab, obinutuzumab, Enbrel, and ofatumumab, or a biosimilar version thereof.

Details for Patent 10,485,797

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Genentech, Inc. RITUXAN rituximab Injection 103705 11/26/1997 ⤷  Try a Trial 2034-12-18
Immunex Corporation ENBREL etanercept For Injection 103795 11/02/1998 ⤷  Try a Trial 2034-12-18
Immunex Corporation ENBREL etanercept For Injection 103795 05/27/1999 ⤷  Try a Trial 2034-12-18
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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