Selected EMA news, 2021

December 2021

Positive CHMP opinions on new medicines

  • Tavneos (avacopan) – Orphan Medicine
    Treatment of granulomatosis with polyangiitis or microscopic polyangiitis

November 2021

Positive CHMP opinions on new medicines

  • Aspaveli (pegcetacoplan)
    Treatment of paroxysmal nocturnal haemoglobinuria

New medicines authorized

  • Imatinib Koanaa (imatinib) generic of Glivec
    Treatment of blood cancers and gastrointestinal stromal tumors

New information on authorized medicines

  • Hizentra (human normal immunoglobulin (SCIg) – Extension of indication
    Treatment of immunologic deficiency syndromes

October 2021

Positive CHMP opinions on new medicines

  • Brukinsa (zanubrutinib) – Orphan medicine
    Treatment of Waldenström’s macroglobulinaemia

September 2021

New medicine authorized

  • Evrenzo (roxadustat)
    Treatment of anaemia symptoms (low red blood cell counts) caused by chronic kidney failure

August 2021

Positive CHMP opinions on new medicines

  • Imatinib Koanaa (imatinib)
    Treatment of leukaemia and gastrointestinal stromal tumours

New information on authorized medicines

  • Ultomiris (ravulizumab) – extension of indication
    Treatment of paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome

Negative CHMP opinions on extension of indication

  • Siklos (hydroxycarbamide)
    Intended to extend the use of Siklos to include the treatment of severe chronic (long-term)
    anaemia in patients suffering from sickle cell syndrome

Safety update

  • Review of Zynteglo (betibeglogene autotemcel) – CHMP Opinion
    Treatment of beta thalassaemia

July 2021

Positive CHMP opinions on new medicines

  • Evrenzo (roxadustat)
    Treatment of anaemia symptoms in patients with chronic kidney disease

New medicines authorized

  • Inrebic (fedratinib) Orphan Medicine
    Treatment of myelofibrosis
  • Onureg (azacitidine)
    Treatment of acute myeloid leukaemia

April 2021

Positive CHMP opinions on new medicines

  • Copiktra (duvelisib)
    Treatment of relapsed or refractory chronic lymphocytic leukaemia and refractory follicular lymphoma

New medicines authorized

Negative CHMP opinions on new medicines

Withdrawal of applications to change the marketing authorization

Safety update

March 2021

Positive CHMP opinions on new medicines

  • Nexpovio (selinexor)
    Treatment of multiple myeloma (cancer of the bone marrow)
  • Thiotepa Riemser (thiotepa) generic of Tepadina
    Treatment prior to blood-stem cell transplantation

New medicines authorized

  • Lenalidomide KrKa (lenalidomide) generic of Revlimid
    Treatment of multiple myeloma and follicular lymphoma (blood cancers)
  • Lenalidomide KrKa d.d. (lenalidomide) generic of Revlimid
    Treatment of multiple myeloma, myelodysplastic syndromes, and follicular lymphoma (blood cancers)
  • Lenalidomide KrKa d.d. Novo mesto (lenalidomide) generic of Revlimid
    Treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma (blood cancers)

New information on authorized medicines

  • Sarclisa (isatuximab) – extension of indication
    Treatment of multiple myeloma (blood cancer)

Withdrawal of authorized medicines

  • Udenyca (pegfilgrastim)
    Treatment of neutropenia (low level of white blood cells)

Other information

Direct Healthcare Professional Communication (DHPC)

February 2021

New medicines authorized

  • Elzonris (tagraxofusp) Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN)
  • Tecartus (Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured) Treatment of mantle cell lymphoma – Orphan Medicine

January 2021

Positive CHMP opinions on new medicines

  • Inrebic (fedratinib) – Orphan Medicine
    Treatment of of primary myelofibrosis and of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia
  • Lenalidomide KrKa (lenalidomide) – generic of Revlimid
    Treatment of multiple myeloma and follicular lymphoma
  • Lenalidomide KrKa d.d. (lenalidomide) – generic of Revlimid
    Treatment of multiple myeloma, myelodysplastic syndromes and follicular lymphoma
  • Lenalidomide KrKa d.d. Novo mesto (lenalidomide) – generic of Revlimid
    Treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma
  • Lumoxiti (moxetumomab pasudotox)
    Treatment of relapsed or refractory hairy cell leukaemia – Orphan Medicine, Exceptional Circumstances

New information on authorized medicines

  • Nplate (romiplostim) – extension of indication
    Treatment of patients with long-term immune thrombocytopenic purpura (ITP), a disease in which the patient’s immune system destroys platelets

New information on authorized medicines

  • Doptelet (avatrombopag) – new indication Treatment of severe thrombocytopenia in patients with chronic liver disease