Selected EMA news, 2024

December 2024

New information on approved medicines

  • Sarclisa (isatuximab) – new indication
    Treatment of multiple myeloma (a type of blood cancer)

Withdrawal of applications for extension of indication

  • Inaqovi (cedazuridine / decitabine)
    Treatment of different types of blood cancer

Direct Healthcare Professional Communication (DHPC)

  • Pegasys (peginterferon alfa-2a)
    Treatment of polycythaemia vera (a disease in which the body produces too many red blood cells), essential thrombocythaemia (a disease in which there are too many platelets in the blood), hepatitis B and C

November 2024

New medicines recommended for approval

  • Eltrombopag Viatris (eltrombopag) – generic
    Treatment of primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C (disease in which patients have low levels of blood platelets)
  • Alhemo (concizumab)
    Prevention of bleeding in patients with hemophilia A or hemophilia B

Supply shortages

  • Pegasys (peginterferon alfa-2a)
    Treatment of polycythaemia vera (a disease in which the body produces too many red blood cells), essential thrombocythaemia (a disease in which there are too many platelets in the blood), and hepatitis B and C (diseases of the liver due to infection with the hepatitis B and C viruses)

October 2024

New medicines recommended for approval

  • Pomalidomide Teva (pomalidomide) – generic
    Treatment of multiple myeloma (a type of blood cancer)
  • Hympavzi (marstacimab) – orphan medicine
    Treatment of bleeding episodes

New information on approved medicines

  • Darzalex (daratumumab) – new indication – orphan medicine
    Treatment of multiple myeloma (a type of blood cancer)
  • Esperoct (turoctocog alfa pegol) – extension of indication
    Treatment and prevention of bleeding

Direct Healthcare Professional Communication (DHPC)

  • Oxbryta (voxelotor) – Suspension of EU marketing authorization
    Treatment of anaemia in patients with sickle cell disease

September 2024

Safety update

  • Withdrawal of Oxbryta (Voxelotor) – marketing authorization suspended
    Treatment of haemolytic anaemia (excessive breakdown of red blood cells) due to sickle cell disease

New medicines approved

  • Adzynma (rADAMTS13) – orphan medicine
    Treatment of congenital thrombotic thrombocytopenic purpura (an inherited clotting disorder)

Other EMA news

  • EMA’s safety committee, PRAC, has recommended measures to minimize the serious outcomes of agranulocytosis, a known side effect caused by the painkiller metamizole.

August 2024

Safety update

  • Review of Oxbryta (Voxelotor) – review started
    Treatment of haemolytic anaemia (excessive breakdown of red blood cells) due to sickle cell disease

Direct Healthcare Professional Communication (DHPC)

July 2024

Positive CHMP opinions on new medicines

  • Nilotinib Accord (nilotinib) – generic
    Treatment of chronic myelogenous leukaemia (blood cancer)
  • Ordspono (odronextamab) – orphan medicine
    Treatment of different kind of blood cancers
  • Piasky (crovalimab)
    Treatment of paroxysmal nocturnal haemoglobinuria (a condition in which there is excessive breakdown of red blood cells)

New medicines authorized

  • Fabhalta (Iptacopan) – orphan medicine
    Treatment of paroxysmal nocturnal haemoglobinuria (a condition in which there is excessive breakdown of red blood cells), thrombosis (blood clots in blood vessels), pancytopenia (low levels of blood cells) and dark urine (due to large amounts of haemoglobin being released into the urine)

New information on authorized medicines

  • Tepkinly (epcoritamab) – new indication – orphan – conditional approval
    Treatment of lymphoma and large B-cell cancer (blood cancers)
  • Pegasys (peginterferon alfa-2a) – extension of indication
    Treatment of polycythaemia vera (blood disease leading to production of too many red blood cells), essential thrombocythaemia (too many platelets in the blood), chronic hepatitis B and C

Safety update

June 2024

Positive CHMP opinions on new medicines

  • Durveqtix (fidanacogene elaparvovec)
    Treatment of haemophilia B
  • Dasatinib Accord Healthcare (dasatinib) – generic of Sprycel
    Treatment of chronic myelogenous leukaemia, a type of blood cancer
  • Pomalidomide Accord (pomalidomide) – generic of Imnovid
    Treatment of multiple myeloma, cancer of the bone marrow
  • Pomalidomide Zentiva (pomalidomide) – generic of Imnovid
    Treatment of multiple myeloma, cancer of the bone marrow

Safety update

  • CAR T-cell medicines (Yescarta, Tecartus, Carvykti, Abecma, Breyanzi, Kymriah) – PRAC recommendation
    Personalized treatment for different types of blood cancer that uses a patient’s own white blood cells (T-cells) to attack the cancer

May 2024

Positive CHMP opinions on new medicines

  • Altuvoct (efanesoctocog alfa)
    Treatment and prevention of bleeding in patients with hemophilia A

April 2024

Positive CHMP opinions on new medicines

  • Fabhalta (iptacopan) – orphan medicine
    Treatment of paroxysmal nocturnal haemoglobinuria (a condition in which there is excessive breakdown of red blood cells)

Withdrawal of applications for new medicines

  • Adcetris (brentuximab vedotin)
    Treatment of certain lymphomas (cancers of lymphocytes, types of white blood cells)

Supply shortages

  • Fludarabine
    Treatment of chronic lymphocytic leukaemia (type of blood cancer)

March 2024

Positive CHMP opinions on new medicines

  • Voydeya (danicopan) – orphan medicine
    Add-on therapy to ravulizumab or eculizumab for the treatment of residual haemolytic anaemia in adult patients with paroxysmal nocturnal haemoglobinuria, rare genetic disorder and potentially life-threatening blood disease leading to the premature destruction of red blood cells (haemolytic anaemia) by the immune system

New information on authorized medicines

  • Carvykti (ciltacabtagene autoleucel) – orphan medicine – conditional approval – extension of indication
    Treatment of relapsed and refractory multiple myeloma (cancer of the bone marrow)
  • Reblozyl (luspatercept) – extension of indication
    Treatment of anaemia (low red blood cell counts)
  • Xromi (hydroxycarbamide) – extension of indication
    Treatment of sickle cell disease

Supply shortages

  • Eldisine (vindesine)
    Treatment of different types of blood cancers, such as acute lymphoblastic leukaemia and chemotherapy-refractory lymphoma, as well as certain solid tumours

February 2024

Positive CHMP opinions on new medicines

  • Ryzneuta (efbemalenograstim alfa)
    Treatment to reduce the duration of neutropenia (low level of white blood cells) and the incidence of febrile neutropenia due to chemotherapy

New information on authorized medicines

  • Aspaveli (pegcetacoplan) – orphan medicine – extension of indication
    Treatment of paroxysmal nocturnal haemoglobinuria (PNH), a condition in which there is excessive breakdown of red blood cells
  • Abecma (idecabtagene vicleucel) – orphan medicine – conditional approval – extension of indication
    Treatment of multiple myeloma (a cancer of the bone marrow)

January 2024

Positive CHMP opinions on new medicines

  • Casgevy (exagamglogene autotemcel) – orphan medicine – conditional approval
    Treatment of transfusion dependent β-thalassemia and sickle cell disease
  • Pomalidomide Viatris (pomalidomide) – generic of Imnovid
    Treatment of multiple myeloma

New information on authorized medicines

  • VeraSeal (human fibrinogen / human thrombin) – extension of indication
    Treatment for stopping bleeding during surgeries

Negative CHMP opinions on renewal of authorized medicine

  • Blenrep (belantamab mafodotin)
    Intended for treatment of multiple myeloma
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