Gyre Therapeutics Announces China’s NMPA Approval of Avatrombopag Maleate Tablets for the Treatment of CLD-Associated Thrombocytopenia
Health Canada Approves DOPTELET (avatrombopag) for Two Indications in Thrombocytopenia
STOCKHOLM, Dec. 11, 2020 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of Doptelet® (avatrombopag) for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). The opinion is now referred to the European Commission for a decision.
A Phase 3 clinical trial evaluating Swedish Orphan Biovitrum AB's (OTCPK:BIOVF) Doptelet (avatrombopag) in solid tumor patients with chemo-induced thrombocytopenia (low blood platelets) failed to achieve the primary endpoint.
The National Institute for Health and Care Excellence (NICE) has published a new final draft guidance recommending Dova Pharmaceuticals’ Doptelet (avatrombopag) for thrombocytopenia - or low platelet count - in people with chronic liver disease needing surgery.
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.
STOCKHOLM, Dec. 9, 2019 /PRNewswire/ -- Dova Pharmaceuticals, a wholly owned subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi™), presented additional analyses from the phase 3 study - core and extension phase - with avatrombopag (AVA) for the treatment of immune thrombocytopenia (ITP), at the 61st Annual Meeting of the American Society of Hematology (ASH) taking place in Orlando, 7-10 December.
Swedish drugmaker Sobi plans on adding another marketed product to its arsenal before year's end, announcing Monday the acquisition of Dova Pharmaceuticals for up to $915 million.
In what some analysts called Dova Pharmaceuticals’ “biggest catalyst to date,” the company won a second FDA nod for its platelet-boosting drug Doptelet, setting the stage for direct competition against Novartis' still-growing blockbuster Promacta.
Bausch Health has yet to fully recover from its tainted past, and a new threat in the form of a rival to its top-seller Xifaxan could pile more pressure on the drugmaker.