Home / FDA News / FDA Grants Orphan Drug Designation to Dova’s Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia

FDA Grants Orphan Drug Designation to Dova’s Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia

DURHAM, N.C., Jan. 13, 2020 /PRNewswire/ — Dova Pharmaceuticals, Inc., a wholly owned subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi™), has been granted Orphan Drug Designation1 (ODD) by the US Food and Drug Administration (FDA) for avatrombopag for the potential treatment of chemotherapy-induced thrombocytopenia (CIT). Enrollment remains ongoing for the phase 3 clinical study of avatrombopag for the treatment of patients with CIT.

ODD is granted by FDA to drugs or biologics intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States. Programs with Orphan Drug status receive partial tax credit for clinical trial expenditures, waived user fees and eligibility for seven years of marketing exclusivity.

“CIT is a potentially serious complication of chemotherapy with no available treatments.  The granting of ODD highlights the significant need for a drug that could improve chemotherapy-induced low platelet counts and thereby enable patients to better adhere to their chemotherapy regimen,” said Mahmood Ladha, President and Head of Dova.

About Chemotherapy-Induced Thrombocytopenia (CIT)

CIT results in low platelet levels and can lead to chemotherapy dose reductions, chemotherapy dose delays, or changes to chemotherapy regimens. For cancer patients receiving chemotherapy with curative intent, alterations in their chemotherapy regimen due to low platelets may compromise their long-term outcomes. Approximately 10 percent of cancer patients in the United States per year experience CIT2 which may require chemotherapy regimen modifications. Currently there are no treatments available for CIT in the United States.

About (avatrombopag) Doptelet®

Doptelet® is an oral thrombopoietin (TPO) receptor agonist administered with food. Doptelet is approved by both the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for treatment of thrombocytopenia (low platelet counts) in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. In June 2019, Doptelet was approved by FDA for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Chronic ITP is a rare autoimmune bleeding disorder characterized by low number of platelets, affecting approximately 60,000 adults in the United States. Avatrombopag is not approved for chemotherapy-induced thrombocytopenia (CIT), a phase 3 study is currently ongoing.

Full prescribing information for DOPTELET is available at www.Dova.com

About Dova Pharmaceuticals

Dova Pharmaceuticals is a wholly owned subsidiary of Swedish Orphan Biovitrum AB (Publ) (Sobi) focused on commercializing Doptelet® (avatrombopag) for the treatment of thrombocytopenia. Doptelet is an oral thrombopoietin (TPO) receptor agonist administered with food. More information is available at www.dova.com. For more information about Sobi, visit www.sobi.com.

 

1 FDA: Developing Products for Rare Diseases & Conditions. https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm  

2 Weycker D et al.  Risk and consequences of chemotherapy-induced thrombocytopenia in US clinical practice. BMC Cancer. 2019;19(1):151.

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