Meet highlights of the Committee for Medical Products for Human Use (CHMP) 19-22. May 2025

Ten new drugs recommended for admission

The Human Medicines Committee (CHMP) from EMA recommended ten medication for approval at its meeting in May 2025.

The committee recommended that a conditional marketing permit for a conditional marketing Aucatzyl* (Obecabtagen AutoLeucel) for the treatment of recurrent or refractory B-cell predecessors of acute lymphoblastic leukemia, a kind of cancer cancer in white blood cells. This drug was supported by the EMA Priority Medicines (Prime) program, which offers early and improved scientific and regulatory support for promising medicines that satisfy the potential to satisfy the non -fulfilled medical needs. Further details in the message termination in the raster below.

A positive opinion was adopted for Blenrep* (Belantamab Mafodotin) for the treatment of recurrent or refractory multiple myeloma, a rare and incurable disease of the plasma plases that typically affects adults aged 60 and over.

The committee recommended that a conditional marketing permit for a conditional marketing Ezmekly* (Mirdamtinib) for the treatment of pediatric and adult patients with neurofibromatosis type 1, a inherited disease in which the patient develops benign (non -cancer -like) tumors along the nerves.

Itovebi (Inavolisib) received a positive opinion from the CHMP for the treatment of adults with a pik3ca-mutated, estrogen receptor (ER)-positive, Her2-negative locally advanced and metastatic breast cancer.

Under exceptional circumstances, the CHMP took a positive opinion for a Maapliv* (Amino acids) for the treatment of maple syrup urine diseases (MSUD) in patients from birth. MSUD is a rare genetic disorder in which the body cannot dismantle certain amino acids contained in proteins. This leads to a structure of harmful substances in the blood and urine, which can lead to serious health problems.

The CHMP recommended the granting of a marketing permit for Riulvy (Tegomil fumarat) for the treatment of adults and children from the age of 13 with recurrent multiple sclerosis, an illness of the brain and the spinal cord, when inflammation, the protective cover itself destroys nerves and nerves. This medicine was submitted in a hybrid application, some of which is based on the results of pre -clinical tests and clinical studies of an already authorized reference product and partly on new data.

The committee adopted positive opinions for three biosimilar medication:

• Bomntra (Denosumab) to prevent skeletal -related events in adults with advanced malignancy, the bones and the treatment of adults and skeletal ripens young people with huge cell tumor of bones.
• Conexxence (Denosumab) for the treatment of osteoporosis of an illness that makes bones fractual after menopause and in men with increased risk of fracture.
• Rolcya (Denosumab) for the treatment of osteoporosis and bone loss.

A generic medicine, Emtricitabine/Tenofovir Alafenamid Viutris (EMTRICITABAIN / TENOFOVIR-Alafenamid) received a positive opinion on the treatment of adults and adolescents who are infected with type 1 (HIV-1) of the human immune deficiency virus.

Negative opinion for two medication

The committee recommended that a marketing permit for pediatric use Atropinsulfate FGK (Atropin), a medication that is intended to treat myopia in children from the age of three.

Kinselby* (Resminostat) received a negative opinion from the CHMP to treat patients with mycosis -fungoides and Sezary syndrome with an advanced stage, two types of cancer from blood cells that mainly affect the skin.

Further information on these negative opinions can be found in the following question and response documents.

Recommendations for expanding therapeutic indication for four medication

The committee recommended extensions for four medication that were already approved in the European Union (EU): IMfinziPresent RezolstaPresent Saxenda And Tevimbra.

Review of recommendations

On June 28, 2024, the European Commission revoked the refusal of a marketing permit for Aplidine (Plitepepsin), a medication that is expected to be used to treat several myelomas. After the acceptance of this decision, the Commission asked EMA to examine the renewed examination of the negative statement of the CHMP again in December 2017.

The owner of the marketing authorization for Winlevi (Clascoterone), a medication that is intended to treat acne vulgaris, examined a new examination of the negative opinion, which was passed during the meeting of the 2025 committee.

After receiving the reasons for these inquiries, the CHMP examines its opinions again and issues final recommendations.

Withdrawal of applications

An application for initial marketing permit was withdrawn. Teriparatid rise (Teriparatide) was intended to treat osteoporosis.

An application to expand the therapeutic indication of LUSTathera (Lutium (177lu) Oxodotreotide) In the treatment of adults with newly diagnosed tumors in the intestine, which is known as a gastroenteropankreatic -Neuroendocrine tumors.

Questions about questions about the withdrawals of these medication are available in the network below.

Conclusion of the transfer

The committee has completed its review of the use of AzithromycinAn antibiotic that has been used for decades to treat a wide range of infectious diseases. The CHMP has recommended several changes, including the revisions and moves of certain indications. These recommendations aim to optimize the use of this common antibiotic and to minimize the development of antimicrobial resistance, to become the ability of microorganisms to become antimicrobial resistance.

Further information on this recommendation can be found in the communication of public health online below.

Start of transfer

The CHMP started checking all available information on the advantages and risks of medication that included Ipidacrine. These drugs have been approved by national interventions in several EU countries and are used in adults to treat different diseases that influence the nervous system. The review of ipidacrin-containing drugs was initiated at the request of the Irish drug regulatory authority in accordance with Article 31 of Directive 2001/83/EC.

For more information, see public health communication online below.

Agenda and minutes

The agenda of the CHMP meeting in May 2025 will be published on the EMA website. The minutes of the meeting will be published in the coming weeks.

CHMP statistics

The most important figures from the CHMP meeting in May 2025 are shown in the graphic below.

*This product was shown as Orphan medicine during its development. Orphan names are checked at the time of admission by the EMA Committee for Orphan Medicinal Products (Comp) to determine whether the information available so far enables the orphan status of medicine and the granting of medicine for ten years.