Selected EMA news, 2020

December 2020

Positive CHMP opinions on new medicines-following re-examination

• Elzonris (tagraxofusp) Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) – Exceptional Circumstances

New medicines authorized

• Adakveo (crizanlizumab) Prevention of recurrent vaso-occlusive crises in patients with sickle cell disease
• Calquence (acalabrutinib) Treatment of chronic lymphocytic leukaemia – Orphan medicine

• Nyvepria (pegfilgrastim) Treatment of neutropenia in cancer patients – Biosimilar of Neulasta

• Phelinun (melphalan ) Treatment of blood and bone marrow cancers and preparing patients for blood stem cell transplants
• Rivaroxaban Accord (rivaroxaban) Treatment and prevention of blood clots – Generic

New information on authorized medicines

• Kyprolis (carfilzomib) – extension of indication Treatment of adult patients with multiple myeloma

Safety update

• Direct healthcare professional communication: Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization

November 2020

Positive CHMP opinions on new medicines

• Lenalidomide Mylan (lenalidomide) – Generic
  Treatment of multiple myeloma and follicular lymphoma (blood cancers)

New medicines authorized

• Arsenic trioxide medac (arsenic trioxide) – Generic
  Treatment of acute promyelocytic leukaemia (blood cancer)

New information on authorized medicines

• Blincyto (blinatumomab) – extension of indication – Orphan medicine
  Treatment of B-precursor acute lymphoblastic leukaemia (a type of blood cancer)

Safety update

• Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)

October 2020

Positive CHMP opinions on new medicines

• Nyvepria (pegfilgrastim) – Biosimilar of Neulasta
  Treatment of neutropenia in cancer patients
• Rivaroxaban Accord (rivaroxaban) – Generic
  Treatment and prevention of blood clots

New medicines authorized

• Blenrep (belantamab mafodotin) – Conditional Approval – Orphan Medicine
  Treatment of multiple myeloma

Re-examination request following negative CHMP opinions on new medicines

• Elzonris (tagraxofusp)
  Intended for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive type of blood cancer

August 2020

Positive CHMP opinions on new medicines

• Adakveo (crizanlizumab)
  Prevention of recurrent vaso-occlusive crises in patients with sickle cell disease
• Arsenic trioxide medac (arsenic trioxide)
  Treatment of acute promyelocytic leukaemia
• Calquence (acalabrutinib) – Orphan Medicine
  Treatment of chronic lymphocytic leukaemia

New medicines authorized

• Daurismo (glasdegib)
  Treatment of acute myeloid leukaemia (blood cancer)
• Reblozyl (luspatercept) – Orphan Medicine
  Treatment of anaemia caused by myelodysplastic syndromes (MDS) or betathalassaemia

New information on authorized medicines

• Crysvita (burosumab) – change and extension of indication – Orphan Medicine – Conditional Approval
  Treatment of X-linked hypophosphataemia
• Imbruvica (ibrutinib) – extension of indication – Orphan Medicine
  Treatment of blood cancers
• NovoThirteen (catridecacog)- extension of indication
  Prevention of bleeding in patients with inherited blood clotting disorder

Negative CHMP opinions on new medicines

• Gamifant (emapalumab)
  Intended for the treatment of primary haemophagocytic lymphohistiocytosis (HLH)