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Details:
Reblozyl (luspatercept) is a first-in-class TGF beta inhibitor, which is being evaluated for the treatment of transfusion-dependent anemia due to low- to intermediate-risk myelodysplastic syndromes.
Lead Product(s): Luspatercept
Therapeutic Area: Oncology Product Name: Reblozyl
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 02, 2024
Details:
Reblozyl (luspatercept) is a first-in-class TGF beta inhibitor, which is being evaluated for the treatment of transfusion-dependent anemia due to low- to intermediate-risk myelodysplastic syndromes.
Lead Product(s): Luspatercept
Therapeutic Area: Oncology Product Name: Reblozyl
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2024
Details:
Reblozyl (luspatercept) is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia based on interim results from pivotal Phase 3 COMMANDS trial, expanding approved population to ESA-naïve patients.
Lead Product(s): Luspatercept
Therapeutic Area: Oncology Product Name: Reblozyl
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 28, 2023
Details:
Reblozyl (luspatercept-aamt) is a recombinant fusion protein that binds several endogenous TGF-β superfamily ligands, thereby diminishing Smad2/3 signaling. It is being investigated for anemia in adults with lower-risk myelodysplastic syndromes.
Lead Product(s): Luspatercept
Therapeutic Area: Oncology Product Name: Reblozyl
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 2023
Details:
Reblozyl (luspatercept-aamt) is a recombinant fusion protein that binds several endogenous TGF-β superfamily ligands, thereby diminishing Smad2/3 signaling thus, improved hematology parameters associated with ineffective erythropoiesis.
Lead Product(s): Luspatercept
Therapeutic Area: Genetic Disease Product Name: Reblozyl
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2023
Details:
Reblozyl (luspatercept-aamt) is a recombinant fusion protein that binds several endogenous TGF-β superfamily ligands, thereby diminishing Smad2/3 signaling thus, improved hematology parameters associated with ineffective erythropoiesis.
Lead Product(s): Luspatercept
Therapeutic Area: Genetic Disease Product Name: Reblozyl
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2023
Details:
Reblozyl (luspatercept-aamt), a first-in-class therapeutic option, promotes late-stage RBC maturation in animal models. Reblozyl is approved in the U.S. for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions.
Lead Product(s): Luspatercept
Therapeutic Area: Oncology Product Name: Reblozyl
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 31, 2022
Details:
Reblozyl (luspatercept-aamt) first-in-class therapeutic option, promotes late-stage red blood cell maturation in animal models, is currently approved in the U.S. for treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions.
Lead Product(s): Luspatercept
Therapeutic Area: Genetic Disease Product Name: Reblozyl
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Acceleron Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2022
Details:
The sBLA was based on safety and efficacy results from the pivotal Phase 2 BEYOND study evaluating Reblozyl, a first-in-class therapeutic option plus best supportive care in adults with NTD beta thalassemia.
Lead Product(s): Luspatercept
Therapeutic Area: Genetic Disease Product Name: Reblozyl
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2022
Details:
Submission based on results from Phase 2 BEYOND study of Reblozyl® (luspatercept-aamt) best supportive care in adults with Non-Transfusion Dependent beta thalassemia.
Lead Product(s): Luspatercept
Therapeutic Area: Genetic Disease Product Name: Reblozyl
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2021
Details:
Results showed treatment with Reblozyl plus best supportive care improved anemia in 77% of patients compared to placebo. Reblozyl was generally well tolerated and improvements in hemoglobin correlated with improved patient-reported outcomes over a continuous 12-week interval.
Lead Product(s): Luspatercept
Therapeutic Area: Genetic Disease Product Name: Reblozyl
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Acceleron Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2021
Details:
Data analyses from the Phase 3 MEDALIST and BELIEVE trials find treatment with luspatercept maintains health-related quality of life in patients with lower-risk myelodysplastic syndromes and transfusion-dependent beta-thalassemia, respectively.
Lead Product(s): Luspatercept
Therapeutic Area: Hematology Product Name: Reblozyl
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
Health Canada has approved REBLOZYL® (luspatercept) for the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta(β)-thalassemia.
Lead Product(s): Luspatercept
Therapeutic Area: Hematology Product Name: Reblozyl
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2020
Details:
This approval is based on data from the pivotal Phase 3 MEDALIST and BELIEVE studies, evaluating the ability of Reblozyl to effectively address anemia associated with MDS and beta thalassemia, respectively.
Lead Product(s): Luspatercept
Therapeutic Area: Hematology Product Name: Reblozyl
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 26, 2020
Details:
Data from multiple studies, including results in the outpatient administration setting and using machine learning technology, evaluating potential of CAR T liso-cel in relapsed and refractory large b-cell lymphoma.
Lead Product(s): Luspatercept
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2020
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