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
- Inrebic (fedratinib) – Orphan Medicine
Treatment of myelofibrosis
Negative CHMP opinions on new medicines
- Gamifant (emapalumab)
Intended for the treatment of primary haemophagocytic lymphohistiocytosis (HLH)
Withdrawal of applications to change the marketing authorization
- Brilique (ticagrelor)
Intended to be used with aspirin to prevent problems caused by blood clots
Safety update
- Review of Zynteglo (betibeglogene autotemcel) – review started (Art. 20)
Treatment of a blood disorder known as beta thalassaemia
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
- Precautionary marketing suspension of thalassaemia medicine Zynteglo (betibeglogene autotemcel)
Direct Healthcare Professional Communication (DHPC)
- Lojuxta (lomitapide): Reminder to monitor the liver function of patients treated with Lojuxta and to avoid use in pregnancy
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