MedPath

Lanadelumab

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

Efficacy and Safety of Lanadelumab (SHP643) in Japanese Participants With Hereditary Angioedema (HAE)

Phase 3
Completed
Conditions
Hereditary Angioedema (HAE)
Interventions
First Posted Date
2019-11-27
Last Posted Date
2022-09-30
Lead Sponsor
Shire
Target Recruit Count
12
Registration Number
NCT04180163
Locations
🇯🇵

Kobe University Hospital, Kobe-shi, Hyogo-Ken, Japan

🇯🇵

Asahi General Hospital, Asahi-shi, Chiba-Ken, Japan

🇯🇵

Ogaki Municipal Hospital, Ogaki-shi, Gifu-Ken, Japan

and more 9 locations

A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children

Phase 3
Completed
Conditions
Hereditary Angioedema
Interventions
First Posted Date
2019-08-28
Last Posted Date
2022-05-26
Lead Sponsor
Shire
Target Recruit Count
21
Registration Number
NCT04070326
Locations
🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇩🇪

Charité - Universitätsmedizin Berlin., Berlin, Germany

and more 14 locations

Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2018-01-17
Last Posted Date
2021-06-03
Lead Sponsor
Shire
Target Recruit Count
32
Registration Number
NCT03401671
Locations
🇺🇸

WCCT Global, Inc., Cypress, California, United States

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