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Swedish Orphan therapy for low platelet count gets orphan-drug tag from US FDA

Swedish Orphan Biovitrum AB (publ) said the U.S. Food and Drug Administration granted orphan-drug designation to its drug avatrombopag for treating chemotherapy-induced thrombocytopenia, or CIT.

CIT, a complication of chemotherapy, causes low platelet levels and can lead to chemotherapy dose reductions and delays as well as changes to chemotherapy regimens. These effects can compromise a cancer patient's long-term outcomes.

The U.S. FDA grants orphan-drug designation to therapies used to treat, diagnose or prevent rare disorders that affect fewer than 200,000 people in the U.S. Treatments granted the designation are given incentives such as tax credits and market exclusivity if approved.

Stockholm-based Swedish Orphan Biovitrum is evaluating avatrombopag in a late-stage study for patients with CIT.

Avatrombopag, also known as Doptelet, is already approved in the U.S. and EU for treating thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure, and in the U.S. for treating thrombocytopenia in adults with chronic immune thrombocytopenia who have had an insufficient response to a previous therapy.

Doptelet was acquired by Swedish Orphan when it bought Durham, N.C.-based Dova Pharmaceuticals Inc. in September in a deal worth up to $915 million.