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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/02/20 | Phase 2 | Active, not recruiting | |||
2019/12/20 | Phase 3 | Completed | |||
2019/11/27 | Phase 3 | Completed | |||
2019/08/28 | Phase 3 | Completed | |||
2019/04/17 | Phase 1 | Completed | |||
2018/01/17 | Phase 1 | Completed | |||
2016/04/18 | Phase 3 | Completed | |||
2014/03/21 | Phase 1 | Completed | |||
2013/08/15 | Phase 1 | Completed |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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