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,Thrombin

            Therapeutic Area: Hematology Product Name: TachoSil

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Corza

            Deal Size: $407.9 million Upfront Cash: $407.9 million

            Deal Type: Divestment September 16, 2020

            Details:

            Under the terms of the agreement, upon close, Corza Health will acquire the assets and licenses that support the development and commercialization of TachoSil®, while Takeda will maintain ownership of the manufacturing facility in Linz, Austria.

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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 September 03, 2020

            Details:

            The Company's vadadustat development program also includes two other global Phase 3 studies (INNO2VATE) for the treatment of anemia due to CKD in adult patients on dialysis, for which the Company reported positive top-line data in May.

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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 July 30, 2020

            Details:

            PNH with Extravascular Hemolysis (EVH): Alexion plans to initiate a Phase 3 study of ALXN2040 as an add-on therapy for PNH patients with EVH by the end of 2020.

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            Lead Product(s): Fostamatinib Disodium

            Therapeutic Area: Hematology Product Name: Tavalisse

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Grifols International

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 09, 2020

            Details:

            TAVLESSE, which is marketed in the U.S. under the brand name TAVALISSE®, is an oral spleen tyrosine kinase (SYK) inhibitor that targets the underlying autoimmune cause of ITP by impeding platelet destruction.

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            Lead Product(s): Coagulation factor Xa (recombinant), inactivated-zhzo

            Therapeutic Area: Hematology Product Name: Andexxa

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Alexion Pharmaceuticals

            Deal Size: $1,400.0 million Upfront Cash: Undisclosed

            Deal Type: Acquisition July 02, 2020

            Details:

            The acquisition adds Factor Xa inhibitor reversal agent Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], marketed as Ondexxya® in Europe, to Alexion’s commercial portfolio.

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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 June 26, 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.

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            Lead Product(s): Coagulation factor Xa (recombinant), inactivated-zhzo

            Therapeutic Area: Hematology Product Name: Andexxa

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Alexion Pharmaceuticals

            Deal Size: $1,400.0 million Upfront Cash: Undisclosed

            Deal Type: Acquisition May 05, 2020

            Details:

            The acquisition expands and diversifies Alexion’s hematology, neurology and critical care commercial portfolio with transformative Factor Xa inhibitor reversal agent.

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            Lead Product(s): Human fibrinogen,Thrombin

            Therapeutic Area: Hematology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Johnson & Johnson

            Deal Size: $400.0 million Upfront Cash: Undisclosed

            Deal Type: Termination April 10, 2020

            Details:

            In late March, EU antitrust regulators had expressed concern about the deal and opened a full investigation into it.

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            Lead Product(s): Patisiran

            Therapeutic Area: Hematology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Alnylam Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement March 25, 2020

            Details:

            Partnership with Gen enables Alnylam to extend access to ONPATTRO to patients suffering from hereditary ATTR amyloidosis with polyneuropathy in Turkey.

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