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.
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/10 | Phase 4 | Recruiting | Bernstein Clinical Research Center | ||
2022/07/15 | Phase 3 | Completed | |||
2022/05/31 | N/A | Recruiting | |||
2022/03/28 | Phase 2 | Recruiting | |||
2021/04/19 | Phase 1 | Active, not recruiting | |||
2020/10/19 | Phase 3 | Completed | |||
2020/10/12 | N/A | NO_LONGER_AVAILABLE | |||
2020/08/07 | Phase 1 | Completed | |||
2020/07/07 | Phase 1 | Withdrawn | |||
2020/06/24 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Takeda Pharmaceuticals America, Inc. | 47783-645 | SUBCUTANEOUS | 150 mg in 1 mL | 2/8/2023 | |
| Takeda Pharmaceuticals America, Inc. | 47783-646 | SUBCUTANEOUS | 300 mg in 2 mL | 2/8/2023 | |
| Takeda Pharmaceuticals America, Inc. | 47783-644 | SUBCUTANEOUS | 300 mg in 2 mL | 2/8/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/22/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Lanadelumab Injection | 国药准字SJ20200025 | 生物制品 | 注射剂 | 12/2/2020 | |
| Lanadelumab Injection | 国药准字SJ20255003 | 生物制品 | 注射剂 | 5/9/2025 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| TAKHZYRO lanadelumab 150 mg/1 mL solution for injection pre-filled syringe | 409942 | Medicine | A | 7/25/2024 | |
| TAKHZYRO lanadelumab 300mg/2mL solution for injection vial | 302300 | Medicine | A | 1/30/2019 | |
| TAKHZYRO lanadelumab 300 mg/2 mL solution for injection pre-filled syringe | 330280 | Medicine | A | 6/15/2020 |
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