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Find Approved Hematology Drugs in Clinical Development

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            Lead Product(s): Pegfilgrastim

            Therapeutic Area: Hematology Product Name: Nyvepria

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 11, 2020

            Details:

            The FDA approval was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NYVEPRIA to its reference product.

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            Lead Product(s): Human Fibrinogen

            Therapeutic Area: Hematology Product Name: Fibryga

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 03, 2020

            Details:

            Octapharma to present multiple clinical trial posters on the efficacy and safety of fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use to treat congenital and acquired bleeding disorders.

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            Lead Product(s): Roxadustat

            Therapeutic Area: Hematology Product Name: Evrenzo

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: FibroGen, Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 27, 2020

            Details:

            The MHLW approval of EVRENZO marks the second approval in Japan for roxadustat through the Astellas and FibroGen collaboration, after the therapy was approved and launched for use in adult patients with anemia of CKD on dialysis last year.

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            Lead Product(s): Ferumoxytol

            Therapeutic Area: Hematology Product Name: Feraheme

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Covis Pharma

            Deal Size: $647.0 million Upfront Cash: $647.0 million

            Deal Type: Acquisition November 16, 2020

            Details:

            The acquisition adds AMAG's key products Feraheme®, Makena® and Ciraparantag to Covis' pipeline as it carries out its mission of expanding patient access to much needed therapies.

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            Lead Product(s): Vadadustat

            Therapeutic Area: Hematology Product Name: Vafseo

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 16, 2020

            Details:

            INNO2VATE evaluated the efficacy and safety of vadadustat, Akebia's investigational oral HIF-PHI, versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis.

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            Lead Product(s): Ravulizumab

            Therapeutic Area: Hematology Product Name: Ultomiris

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 04, 2020

            Details:

            New data from 2 Phase 3 extension trials showing similar safety, consistent and durable efficacy of ULTOMIRIS® through 52 weeks when used to treat adults with paroxysmal nocturnal hemoglobinuria who are 65 and above than those who are 65 years old or younger to be presented.

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            Lead Product(s): Luspatercept

            Therapeutic Area: Hematology Product Name: Reblozyl

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 04, 2020

            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.

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            Lead Product(s): Avatrombopag

            Therapeutic Area: Hematology Product Name: Doptelet

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 04, 2020

            Details:

            Doptelet (avatrombopag) is designed to mimic the biologic effects of thrombopoietin in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count, according to Sobi.

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            Lead Product(s): Vadadustat

            Therapeutic Area: Hematology Product Name: Vafseo

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 23, 2020

            Details:

            PRO2TECT data show vadadustat achieved primary and key secondary efficacy endpoints in each study, but did not meet the primary safety endpoint.

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            Lead Product(s): Ravulizumab

            Therapeutic Area: Hematology Product Name: Ultomiris

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 12, 2020

            Details:

            ULTOMIRIS 100 mg/mL is an advancement in the treatment experience for patients with aHUS and PNH, as it reduces average annual infusion times by approximately 60 percent compared to ULTOMIRIS 10 mg/mL while delivering comparable safety and efficacy.

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