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Pamrevlumab (INN; [1] development code FG-3019) is a humanized monoclonal antibody designed for the treatment of idiopathic pulmonary fibrosis and pancreatic cancer. It binds to the connective tissue growth factor (CTGF) protein.
Sutimlimab was approved for medical use in the United States in February 2022, [3] [7] and in the European Union in November 2022. [2] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication .
Mavrilimumab is a human monoclonal antibody [1] that inhibits human granulocyte macrophage colony-stimulating factor receptor (GM-CSF-R). [2]Mavrilimumab was discovered as CAM-3001 by Cambridge Antibody Technology and is being developed by MedImmune, Inc. [1] as an investigational drug for the treatment of rheumatoid arthritis
Clinical trial number NCT05232825 for "A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis (Ocarina II)" at ClinicalTrials.gov
The US Food and Drug Administration (FDA) evaluated the safety and efficacy of retifanlimab based on PODIUM-201 (NCT03599713), an open-label, multiregional, single-arm study evaluating 65 participants with metastatic or recurrent locally advanced MCC who had not received prior systemic therapy for advanced disease.
In March 2019 CytoDyn filed with the US FDA the first part of the BLA for leronlimab (PRO140) as a combination therapy with HAART in HIV. In December 2019, the company affirmed plans to complete the BLA in January 2020 with potential FDA approval in 2Q'20. CytoDyn is also conducting an investigative monotherapy trial of leronlimab (PRO140) for HIV.
In the clinical trials that lead to emapalumab's FDA approval, the most commonly reported adverse effects were infections (56%), high blood pressure (41%), infusion reactions (27%), and fever (24%). [ 2 ] [ 8 ] Serious adverse effects occurred in about half of the subjects studied in the clinical trial that led to its FDA approval.
This is the second candidate from a deal with Cambridge Antibody Technology that Abbott have taken to late-stage clinical trials. As a result of the protracted royalty dispute over Humira Abbott agreed to pay CAT a reduced royalty of 4.75% on any future sales of ABT-874, from which CAT will pay a portion to the MRC and other licensors (according to CAT's 1997 agreement with the MRC).