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Pharmaceutical composition for treating aplastic anemia

An aplastic and composition technology, which is applied in the fields of drug combination, drug delivery, blood diseases, etc., can solve the problem of ineffectiveness, and achieve the effect of high drug efficacy and realization of drug efficacy.

Pending Publication Date: 2021-06-01
KYOWA HAKKO KIRIN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] For patients with severe AA who do not respond to immunosuppressive therapy, it is expected that the combination of EPAG will improve the therapeutic effect, but according to the clinical trial data of EPAG in Japanese AA patients not treated with ATG, there are patients who do not respond even with EPAG

Method used

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  • Pharmaceutical composition for treating aplastic anemia
  • Pharmaceutical composition for treating aplastic anemia
  • Pharmaceutical composition for treating aplastic anemia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Phase II clinical (Ph2) trial

[0078] Patients with aplastic anemia unresponsive to immunosuppressive therapy (hereinafter also referred to as subjects) were subjected to a randomized open-label parallel intergroup comparative dosage setting test (Ph2 test) according to the following protocol.

[0079] During administration

[0080] ■Dosage fixed period (initial dosage evaluation period): 1st to 8th week

[0081] Romigrastim was administered at any dosage of 1 μg / kg, 3 μg / kg, 6 μg / kg, or 10 μg / kg once a week for 8 weeks.

[0082] Except when the discontinuation criteria of the following 3) are met, the initial dose is maintained during this period, and the dose is not adjusted.

[0083] ■Continued administration period: 9th to 52nd week

[0084] The starting dosage of the continuous administration period is determined for each patient based on the efficacy and safety data in the dosage fixed period (initial dosage evaluation period). If no platelet response is ...

Embodiment 2

[0119] Phase II / III clinical (Ph2 / 3) trials

[0120] For patients with aplastic anemia who do not respond to immunosuppressive therapy or who are not suitable for immunosuppressive therapy, the international joint open-label intra-individual dose adjustment phase II / III clinical trial will be implemented according to the following procedures.

[0121] Administration period (1st to 52nd week)

[0122] Romigrastim was administered subcutaneously once a week as follows.

[0123] ■A fixed dosage period (1st to 4th week)

[0124] The dosage at the beginning of administration was set at 10 μg / kg, and the dosage was set at a fixed dosage during the first to fourth weeks.

[0125] ■Continued administration period (5th to 52nd week)

[0126] After the fifth week, the dosage can be adjusted according to the dosage adjustment method below.

[0127] Dosage adjustment method

[0128] 1) Increment of dosage

[0129] When no platelet reaction was confirmed for 4 consecutive weeks...

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Abstract

The present invention pertains to a pharmaceutical composition for treating aplastic anemia, comprising romiplostim as an active ingredient. This pharmaceutical composition is characterized by: being administered subcutaneously once a week; and in that for the first four weeks after the start of administration, the amount administered is 10 mcg / kg / week in terms of romiplostim, and from the fifth week, the amount is increased beyond 10 mcg / kg / week, up to 20 mcg / kg / week in terms of romiplostim.l.

Description

technical field [0001] [Related application] [0002] This specification includes the contents described in the specification of Japanese Patent Application No. 2018-202097 (filed on October 26, 2018), which is the basis of the priority of this application. [technical field] [0003] The invention relates to a pharmaceutical composition for treating aplastic anemia with romigrastim as an active ingredient. Background technique [0004] Aplastic Anemia (AA) is a disease characterized by a decrease in all blood cells in the peripheral blood (pancytopenia) and a decrease in the cell density of the bone marrow (hypogenesis). As subjective symptoms of AA, symptoms of anemia such as shortness of breath, palpitations, and dizziness during work, fever due to infection, and bleeding tendencies such as subcutaneous bleeding spots, gingival bleeding, and nosebleeds can be observed. As he perceives, pallor, anemia-like eyelid conjunctiva, subcutaneous hemorrhage, gingival hemorrhage...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/16A61K38/36A61P7/06
CPCA61P7/06A61K38/196A61K38/36A61K9/0021
Inventor 辻幸惠儿玉都
Owner KYOWA HAKKO KIRIN CO LTD