Newly released phase 3 results have shown that lanadelumab, Shire plc’s experimental hereditary angioedema (HAE) drug, reduced monthly attack rates and improved quality of life compared with placebo. Recently presented at the 2018 American Academy of Allergy, Asthma, and Immunology meeting, the data helps support lanadelumab’s profile, demonstrating the drug’s efficacy regardless of baseline attack rate or dosing regimen, BioPharma Dive reports.
Lanadelumab is under priority review by the FDA, with a decision expected by August 26. Lanadelumab has been also been granted accelerated assessment by the European Medicines Agency.
Shire announced its plans to sell off its neuroscience unit last year, leaving it with a focus on rare diseases. Lanadelumab is one of its 11 pipeline products currently in phase 3, and U.S. approval could make it the first monoclonal antibody approved for HAE, a serious and potentially life-threatening disease that causes recurrent episodes of severe swelling. The data presented at the meeting adds to results released last May.
“The data on lanadelumab continue to demonstrate the importance of controlling plasma kallikrein activity, which is chronically uncontrolled in those living with HAE—even between attacks,” Marc Riedl, a Clinical Trial Investigator and Professor of Medicine at The University of California San Diego, said in a statement from Shire.
Shire is also conducting phase 3 trials for SHP616 for HAE prophylaxis, and SHP667 is pending approval in Japan for treatment of HAE.
During 2017, Shire won approvals for icatibant (Firazyr) for pediatric HAE and Cinryze (C1 esterase inhibitor [human]) for pediatric HAE prophylaxis. These drugs will compete against CSL Behring’s C1 esterase inhibitor Haegarda, which also secured approval in 2017. Other companies developing HAE therapeutics include BioCryst Pharmaceuticals Inc.; its BCX7353 is set to enter phase 3 trials in 2018.
Source: BioPharma Dive; March 5, 2018.