Latest Hotspot

The Eli Lilly IL-13 inhibitor, lebrikizumab, demonstrates long-term efficacy for the treatment of moderate-to-severe atopic dermatitis

1 November 2023
3 min read

Recently, Eli Lilly announced the long-term therapeutic effects of its investigational IL-13 inhibitor, lebrikizumab, in patients with moderate to severe atopic dermatitis. The results indicated that patients with moderate to severe atopic dermatitis maintained clinical benefits such as clearing of skin symptoms, alleviation of itch, and reduction in disease severity over a two-year extension study with monthly administration of lebrikizumab.

图形用户界面, 文本, 应用程序, 电子邮件

描述已自动生成

Lebrikizumab is a novel anti-IL-13 monoclonal antibody with high bioavailability and a long half-life. It can bind to soluble IL-13 with high affinity and block IL-13 mediated signaling pathways. Previously, Lebrikizumab had received Fast Track designation from the FDA. Lebrikizumab was originally developed by Tanox under the name TNX-650; In 2007, Genentech acquired Tanox, making Lebrikizumab part of Roche's pipeline. Subsequently, in 2017 Dermira paid Roche an upfront payment of $80 million and a total milestone amount of $1.4 billion to acquire the global rights to Lebrikizumab. In June 2019, the European rights to the drug were sold to Almirall. In January 2020, Eli Lilly acquired Dermira for a total of $1.1 billion, with the global rights to Lebrikizumab (excluding Europe) falling into Eli Lilly's hands.

ADjoin is a two-year extension study. Patients were from the monotherapy trials ADvocate 1 and ADvocate 2 and from the lebrikizumab and topical corticosteroid combination trial Adhere. These patients had an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) or a reduction of 75% (EASI-75) from baseline in the average eczema area and severity index after 16 weeks of lebrikizumab treatment and were included in the ADjoin trial. Patients participating in the long-term extension trial needed to receive 250mg of lebrikizumab every two weeks or monthly. In the ADjoin trial, administering lebrikizumab either monthly or every two weeks for two years provided patients with lasting relief from skin symptoms and itch.

图形用户界面, 应用程序, Teams

描述已自动生成

According to information disclosed by the Synapse database, as of October 31,2023, there were 25 investigational drugs targeting IL-13, covering 37 indications, with 47 research institutions involved, and there were 426 related clinical trials and as many as 17,723 patents...On October 2 of this year, the FDA announced that it had refused to approve Eli Lilly's Biologics License Application (BLA) for lebrikizumab for the treatment of moderate to severe atopic dermatitis (eczema). The main reason was that issues were discovered with a third-party Contract Manufacturing Organization (CMO) during inspection. There was no mention in the FDA's CRL of concerns about lebrikizumab's clinical data, safety, or labeling, so if the CMO issues can be effectively resolved, or if production is transferred to a new partner, the waiting time for approval may not be long. We look forward to the early approval of Lebrikizumab.

图形用户界面, 文本, 应用程序

描述已自动生成

Analysis on the Research Progress of COX Inhibitor
Analysis on the Research Progress of COX Inhibitor
1 November 2023
Medicines that inhibit COX can alleviate inflammation and pain symptoms. Medications that inhibit Cyclooxygenase activity, such as aspirin, have been available to the public for around 100 years.
Read →
Abbisko Therapeutics' EGFR exon20ins inhibitor, ABSK112, has been approved for clinical use in China for the treatment of non-small cell lung cancer
Latest Hotspot
3 min read
Abbisko Therapeutics' EGFR exon20ins inhibitor, ABSK112, has been approved for clinical use in China for the treatment of non-small cell lung cancer
1 November 2023
Recently, Abbisko Therapeutics announced that its independently developed next-generation EGFR Exon20ins inhibitor ABSK112 has received approval from the NMPA of China for clinical trial applications.
Read →
KangaBio's IL-12 prodrug molecule immunotherapy, KGX101, has been approved for clinical use in the United States for the treatment of advanced solid tumors
Latest Hotspot
3 min read
KangaBio's IL-12 prodrug molecule immunotherapy, KGX101, has been approved for clinical use in the United States for the treatment of advanced solid tumors
1 November 2023
Recently, KangaBio announced that its independently developed "Tumor-Specific Recombinant IL-12 Fc Fusion Protein for Injection" (pipeline code: KGX101) clinical trial application (IND) has been officially approved by the U.S. FDA.
Read →
Phase 3 clinical results of Johnson & Johnson's IL-23 inhibitor Guselkumab are positive, significantly relieving symptoms in patients with ulcerative colitis
Latest Hotspot
3 min read
Phase 3 clinical results of Johnson & Johnson's IL-23 inhibitor Guselkumab are positive, significantly relieving symptoms in patients with ulcerative colitis
1 November 2023
Recently, Johnson & Johnson announced the results of its Phase 3 clinical trial for its anti-IL-23 antibody Tremfya (guselkumab) in treating moderate to severe ulcerative colitis (UC).
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.