Hematology | Approved Drugs in UNITED STATES

Pfizer Inc

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FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, NYVEPRIA™ (pegfilgrastim-apgf)

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.

Akebia Therapeutics

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Akebia Announces Top-Line Results from its PRO2TECT Global Phase 3 Program of Vadadustat for Treatment of Anemia in CKD Patients

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.

Rigel Pharmaceuticals

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Rigel Announces Availability of TAVLESSE® (Fostamatinib Disodium Hexahydrate) in Europe

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.

Portola Pharmaceuticals

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Alexion Completes Acquisition of Portola

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.

Bristol-Myers Squibb

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EC Clears New Class of Anaemia Therapy from Bristol Myers Squibb

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.

Portola Pharmaceuticals

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Alexion to Acquire Portola

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.

Alnylam Pharmaceuticals

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Alnylam Pharmaceuticals and Gen Sign Distribution Agreement

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.

Rockwell Medical

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Rockwell Medical, Inc. Enters into Exclusive License and Supply Agreements with Sun Pharma for the Rights to Commercialize Triferic® in Ind...

Lead Product(s): FERRIC PYROPHOSPHATE, SOLUBLE

Therapeutic Area: Hematology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Sun Pharmaceutical Industries Limited

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement January 14, 2020

Details:

Under the terms of the agreements, Sun Pharma will be the exclusive development and commercialization partner for Triferic in India and Rockwell Medical will supply the product to Sun Pharma.

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Find Approved Hematology Drugs in Clinical Development in UNITED STATES

United States

Product Type

Companies

Pfizer Inc

FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, NYVEPRIA™ (pegfilgrastim-apgf)

Akebia Therapeutics

Akebia Announces Top-Line Results from its PRO2TECT Global Phase 3 Program of Vadadustat for Treatment of Anemia in CKD Patients

Rigel Pharmaceuticals

Rigel Announces Availability of TAVLESSE® (Fostamatinib Disodium Hexahydrate) in Europe

Portola Pharmaceuticals

Alexion Completes Acquisition of Portola

Bristol-Myers Squibb

EC Clears New Class of Anaemia Therapy from Bristol Myers Squibb

Portola Pharmaceuticals

Alexion to Acquire Portola

Alnylam Pharmaceuticals

Alnylam Pharmaceuticals and Gen Sign Distribution Agreement

Rockwell Medical

Rockwell Medical, Inc. Enters into Exclusive License and Supply Agreements with Sun Pharma for the Rights to Commercialize Triferic® in Ind...