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.
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.
Kobe University Hospital, Kobe-shi, Hyogo-Ken, Japan
Asahi General Hospital, Asahi-shi, Chiba-Ken, Japan
Ogaki Municipal Hospital, Ogaki-shi, Gifu-Ken, Japan
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
WCCT Global, Inc., Cypress, California, United States
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