Treatment options for multiple myeloma

RU2025108416APending Publication Date: 2026-10-05SANOFI SA(FR)
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Patent Information

Application Number
RU2025108416
Authority / Receiving Office
RU · RU
Patent Type
Applications
Current Assignee / Owner
Priority Date
2019-12-04
Filing Date
2025-04-04
Publication Date
2026-10-05
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Claims

1. A liquid pharmaceutical composition containing (a) isatuximab at a concentration of 5-20 mg / ml; (b) a buffering agent selected from the group consisting of histidine, acetate and phosphate; (c) an excipient selected from the group consisting of sucrose and mannitol, and (d) polysorbate 80 (PS80).

2. The liquid pharmaceutical formulation of claim 1, wherein isatuximab is present at a concentration of 5 mg / mL, wherein the buffering agent is histidine, and wherein histidine is present at a concentration of 10 mM, wherein the excipient is sucrose, and wherein sucrose is present at a concentration of 10% (w / v), wherein PS80 is present at a concentration of 0.005% (w / v), and wherein the pharmaceutical formulation is characterized by a pH of about 6.0 or about 6.

5.

3. The liquid pharmaceutical composition according to claim 2, wherein the pH is approximately 6.

5.

4. The liquid pharmaceutical formulation of claim 1, wherein isatuximab is present at a concentration of 20 mg / mL, wherein the buffering agent is histidine, and wherein histidine is present at a concentration of 20 mM, wherein the excipient is sucrose, and wherein sucrose is present at a concentration of 10% (w / v), wherein PS80 is present at a concentration of 0.02% (w / v), and wherein the pharmaceutical formulation is characterized by a pH of approximately 6.

0.

5. The liquid pharmaceutical formulation of claim 1, wherein isatuximab is present at a concentration of 20 mg / ml, wherein the buffering agent is histidine, and wherein histidine is present at a concentration of 1.46 mg / ml, wherein the excipient is sucrose, and wherein sucrose is present at a concentration of 100 mg / ml, wherein PS80 is present at a concentration of 0.2 mg / ml, and wherein the pharmaceutical formulation further comprises histidine hydrochloride monohydrate at a concentration of 2.22 mg / ml.