HemaBites: 2024 September Update from the EMA Committee for Medicinal Products for Human Use

HemaBites showcase hematology news & short commentaries on recent high-impact articles published in international journals.

Did you know that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) publicly releases its monthly meeting highlights? These highlights include medicines recommended for approval, negative opinions on new medicines, recommendations on extensions of therapeutic indication, and more. We are pleased to alert you to this important information, and to specifically feature the hematology-related updates from the committee.

 In September 2024, the CHMP approved 8 new medicines, of note:

• Hympavzi* (marstacimab), received a positive opinion for the treatment of bleeding episodes in patients aged 12 years and older with severe hemophilia A or B

• Granted a marketing authorization for Pomalidomide Teva (pomalidomide), a generic medicine for the treatment of multiple myeloma

The committee recommended additional extensions of indication for 11 medicines that are already authorized in the EU, of note:

• Darzalex* is a medicine used to treat adults with multiple myeloma and light chain (AL) amyloidosis

• Esperoct  is a medicine used to treat and prevent bleeding in patients with hemophilia A

You can access the full CHMP September 2024 meeting highlights freely; click here.

*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.