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Lanadelumab

Generic Name
Lanadelumab
Brand Names
Takhzyro
Drug Type
Biotech
CAS Number
1426055-14-2
Unique Ingredient Identifier
2372V1TKXK

Overview

Lanadelumab, also known as DX-2930, is a human IgG1 monoclonal antibody designed for subcutaneous self-injection. It is a fully human immunoglobulin, k-light-chain made in recombinant Chinese Hamster Ovary cells. The FDA and EU granted the designation of priority review, breakthrough therapy and orphan drug for rare diseases based on the results of the reported clinical trials. Lanadelumab was developed by Shire and FDA approved on August 28, 2018.

Background

Lanadelumab, also known as DX-2930, is a human IgG1 monoclonal antibody designed for subcutaneous self-injection. It is a fully human immunoglobulin, k-light-chain made in recombinant Chinese Hamster Ovary cells. The FDA and EU granted the designation of priority review, breakthrough therapy and orphan drug for rare diseases based on the results of the reported clinical trials. Lanadelumab was developed by Shire and FDA approved on August 28, 2018.

Indication

Lanadelumab is indicated for the prophylaxis treatment to prevent attacks in adult and pediatric patients aged 2 years and older with hereditary angioedema. The hereditary angioedema (HEA) is an autosomal dominant disorder resulted from the presence of C1 deficiency. Some reports have indicated a high prevalence of cases that result from spontaneous mutations which can be inherited. This condition is manifested by attacks of subcutaneous or submucosal edema in the face, larynx, GI tract, limbs or genitalia. From all the types of attacks, the most serious is the laryngeal as it can compromise the airway. The rest of the attacks are accompanied by pain and considerable dysfunction.

Associated Conditions

  • Acute attacks of hereditary angioedema
  • Recurrent Angioedema

FDA Approved Products

TAKHZYRO
Manufacturer:Takeda Pharmaceuticals America, Inc.
Route:SUBCUTANEOUS
Strength:300 mg in 2 mL
Approved: 2023/02/08
NDC:47783-644
TAKHZYRO
Manufacturer:Takeda Pharmaceuticals America, Inc.
Route:SUBCUTANEOUS
Strength:300 mg in 2 mL
Approved: 2023/02/08
NDC:47783-646
TAKHZYRO
Manufacturer:Takeda Pharmaceuticals America, Inc.
Route:SUBCUTANEOUS
Strength:150 mg in 1 mL
Approved: 2023/02/08
NDC:47783-645

Singapore Approved Products

No Singapore products found for this drug

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