Selected EMA news, 2023

November–December 2023

Positive CHMP opinions on new medicines

• Elrexfio (elranatamab) – conditional approval
  Treatment of multiple myeloma

New medicines authorized

• Enrylaze (crisantaspase)
  Treatment of lymphoblastic leukaemia and lymphoblastic lymphoma
• Inaqovi (cedazuridine / decitabine)
  Treatment of myeloid leukaemia
• Tepkinly (epcoritamab) – orphan medicine – conditional approval
  Treatment of blood cancer called diffuse large B-cell lymphoma
• Vanflyta (quizartinib)
  Treatment of myeloid leukaemia

New information on authorized medicines

• Veyvondi (vonicog alfa) – orphan medicine – extension of indication
  Treatment of von Willebrand disease

Special update, November 2023

Electronic Product Information (ePI) for selected human medicines published for first time

EMA, along with the Heads of Medicines Agencies (HMA) and the European Commission (EC) have published for the first time electronic product information (ePI) for selected human medicines harmonized across the European Union.

This forms part of the ePI initiative, a one-year pilot by HMA, EMA, and the EC to enable the transition to an electronic system for medicines evaluated both nationally and at European level.

• More information about the ePI initiative.
• The published ePIs can be viewed at the Product Lifecycle Management Portal.

October 2023

Positive CHMP opinions on new medicines

• Vanflyta (quizartinib) – orphan medicine
  Treatment of acute myeloid leukaemia (blood cancer)

• Elrexfio (elranatamab) – orphan medicine – conditional approval
  Treatment of multiple myeloma (a type of white blood cell cancer)

New medicines authorized

• Talvey (talquetamab) – orphan medicine – conditional approval
  Treatment of multiple myeloma (a type of white blood cell cancer)

New information on authorized medicines

• Adcetris (brentuximab vedotin) – orphan medicine – extension of indication
  Treatment of stage III Hodgkin lymphoma (a cancer of lymphocytes)

Withdrawal of authorized medicines

• EMA recommends non-renewal of authorization of multiple myeloma medicine Blenrep

Withdrawal of applications for extension of indication

• Iclusig (ponatinib)
  Intended for the treatment of adults newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukaemia (blood cancer)

Negative CHMP opinions on renewal of conditional marketing authorization

• EMA recommends non-renewal of authorization of multiple myeloma medicine Blenrep (belantamab mafodotin)

September 2023

Direct Healthcare Professional Communication (DHPC)

• Potential missing package leaflet in folding boxes of RoActemra (tocilizumab), Hemlibra (emicizumab), Herceptin (trastuzumab), Kadcyla (trastuzumab emtansine), MabThera (rituximab), Phesgo (pertuzumab / trastuzumab) and Tecentriq (atezolizumab)
  Treatment of various conditions

August 2023

Positive CHMP opinions on new medicines

• Enrylaze (crisantaspase)
  Treatment of acute lymphoblastic leukaemia (a type of blood cancer)

• Inaqovi (cedazuridine / decitabine) – orphan medicine
  Treatment of myeloid leukaemia (a type of blood cancer)

• Talvey (talquetamab) – orphan medicine – conditional approval
  Treatment of multiple myeloma, a type of white blood cell cancer

• Tepkinly (epcoritamab) – conditional approval
  Treatment of large B-cell lymphoma (a type of blood cancer)

New medicines authorized

• Columvi (glofitamab) – orphan medicine
  Treatment of blood cancer called diffuse large B-cell lymphoma (a type of blood cancer)

Withdrawal of applications for extension of indication

• Gazyvaro (obinutuzumab)
  Intended to prevent a serious side effect (cytokine release syndrome) that occurs with the blood cancer medicine Columvi

Withdrawal of applications for new medicines

• Jesduvroq (daprodustat)
  Treatment of symptomatic anaemia in patients with chronic kidney disease

Direct Healthcare Professional Communication (DHPC)

• Replacement BAXJECT II / BAXJECT II Hi-Flow Reconstitution Devices co-packaged with Advate/Feiba/Rixubis
  Treatment of hemophilia

July 2023

Positive CHMP opinions on new medicines

• Jesduvroq (daprodustat)
  Treatment of anaemia in adults with chronic kidney disease

New information on authorized medicines

• Mircera (methoxy polyethylene glycol-epoetin beta) – extension of indication
  Treatment of anaemia associated with chronic kidney disease in children

• Refixia (nonacog beta pegol) – extension of indication
  Treatment of haemophilia B

Withdrawal of applications for new medicines

• Dyrupeg (pegfilgrastim)
  Intended to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cells in cancer patients)

• Zefylti (filgrastim)
  Intended to stimulate the production of white blood cells

Direct Healthcare Professional Communication (DHPC)

• Adakveo (crizanlizumab) – orphan medicine
  Prevention of painful crises in patients with sickle cell disease

June 2023

New medicines authorized

• Epysqli (Eculizumab)
  Treatment of paroxysmal nocturnal haemoglobinuria, a disease in which excessive breakdown of red blood cells results in various medical complications

• Tibsovo (ivosidenib)
  Treatment of acute myeloid leukaemia (a blood cancer) and biliary tract cancer (cancer of the bile ducts)

• Vafseo (vadadustat)
  Treatment of anaemia (low levels of red blood cells) associated with chronic kidney disease

Supply shortages

• Actilyse (alteplase)
  Treatment of acute pulmonary embolism (blood clot in blood vessels supplying the lung)

Safety update

• Review of Adakveo (crizanlizumab) – CHMP Opinion
  Prevention of painful crises in patients with sickle cell disease

May 2023

New information on authorized medicines

• Adempas (riociguat) – New indication
  Treatment of high blood pressure in lungs in children

Safety update

• Review of Adakveo (crizanlizumab) – review started
  Treatment of painful crises in patients with sickle cell disease

April 2023

Positive CHMP opinions on new medicines

• Epysqli (eculizumab) – Biosimilar
  Treatment of paroxysmal nocturnal heamoglobinuria

New information on authorized medicines

• Ultomiris (ravulizumab) – New indication and new pharmaceutical form
  Treatment of paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)

Withdrawal of applications for new medicines

• Feraheme (ferumoxytol)
  Intended for treatment of iron deficiency anaemia

Safety update

• Review of Pseudoephedrine-containing medicinal products (pseudoephedrine) – review started
  Treatment of nasal congestion

Direct Healthcare Professional Communication (DHPC)

• Janus kinase inhibitors (JAKi) (abrocitinib, filgotinib, baricitinib, upadacitinib, tofacitinib) Updated recommendations to minimize risk of cancer, heart problems and blood clots

March 2023

Positive CHMP opinions on new medicines

• Bekemv (eculizumab) – Biosimilar medicine
  Treatment of paroxysmal nocturnal haemoglobinuria

• Tibsovo (ivosidenib) – Orphan medicine
  Treatment of myeloid leukaemia

• Tidhesco (ivosidenib) – Orphan  medicine
  Treatment of myeloid leukaemia

• Vafseo (vadadustat) Treatment of anaemia associated with chronic kidney disease

New medicines authorized

• Plerixafor Accord (plerixafor) – generic of Mozobil
  Medicine used in cancer patients to obtain cells from the bone marrow for use in transplantation

Direct Healthcare Professional Communication (DHPC)

• Adakveo (crizanlizumab)
  Treatment of anaemia

• Neofordex (dexamethasone)
  Treatment of multiple myeloma

February 2023

New information on authorized medicines

• Reblozyl (luspatercept) – Extension of indication – Orphan medicine
  New indication: Treatment of anemia in patients with beta-thalassaemia

Safety update

• Review of Adakveo (crizanlizumab) – Review started (Scope of safety referral)
• Prevention of painful crises in patients with sickle cell disease