STOCKHOLM, Feb. 25, 2022 /PRNewswire/ -- Sobi® today announces that the Center for Drug Evaluation (CDE) has recommended approval of Gamifant® to the National Medical Products Administration of China (NMPA). The indication is for treatment of adult and paediatric (newborn and older) patients with primary haemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy.
STOCKHOLM, Dec. 10, 2020 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO: SOBI) today announced that a Marketing Authorization Application for emapalumab has been accepted for review in China. The targeted indication is for treatment of adult and paediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.
Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) today announced that the Committee for Medicinal Products for Human use (CHMP) has adopted a negative opinion recommending a refusal of the marketing authorisation for emapalumab for the treatment of primary haemophagocytic lymphohistiocytosis (pHLH) in children under 18 years of age in Europe. The negative opinion was given after the re-examination requested by Sobi after the initial opinon in July 2020.
Sobi bets $250M cash, about $1B in milestones for rights to a C3 therapy being pushed through 5 pivotal trials
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its September 2020 meeting.
The Committee for Medicinal Products for Human use (CHMP) adopted a negative opinion recommending refusal of marketing authourisation for the drug as treatment of primary haemophagocytic lymphohistiocytosis (HLH) in children under 18 years of age in Europe.
At its June 2020 meeting, the human medicines committee of the European Medicines Agency (EMA’s CHMP) recommended that 11 new medicines be approved for use in the European Union (EU); one of these, Dapirivine Vaginal Ring, was recommended under EU Medicines for All, a mechanism for medicines that are also to be used outside the EU.
The EMA has rebuffed Sweden-based Sobi’s pitch for emapalumab, shooting down high hopes for a $568 million drug.
STOCKHOLM, May 7, 2020 /PRNewswire/ -- Sobi™ announced today that the results from the pivotal phase 2/3 study evaluating the efficacy and safety of emapalumab in patients with primary haemophagocytic lymphohistiocytosis (HLH) were published in the New England Journal of Medicine on 7 May 2020. Emapalumab is the first therapy approved by the US Food & Drug Administration (FDA) for primary HLH and is under review by the European Medicines Agency (EMA).