Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024
Ten new medicines recommended for approval; another six medicines recommended for extension of their therapeutic indications
NewsHumanMedicines
Ten new medicines recommended for approval
The committee recommended granting a marketing authorisation for Alhemo (concizumab), a medicine for routine prophylaxis of bleeding in patients with haemophilia A or B with inhibitors, two types of a rare inherited bleeding disorder.
The CHMP adopted positive opinions for two vaccines intended for active immunisation against influenza: Fluad (surface antigen, inactivated, adjuvanted), intended for adults 50 years of age and older, and Flucelvax (surface antigen, inactivated, prepared in cell cultures), for adults and children from two years of age.
Korjuny (catumaxomab) received a positive opinion from the CHMP for the intraperitoneal treatment of malignant ascites, a build-up of fluid containing cancer cells in the abdomen of cancer patients.
The CHMP gave a positive opinion for Siiltibcy (rdESAT-6 / rCFP-10), for the diagnosis of infection with Mycobacterium tuberculosis. According to the World Health Organization, 10.6 million new tuberculosis cases were estimated and 1.6 million people died from the disease in 2021.
Wainzua* (eplontersen) received a positive opinion for the treatment of adults with hereditary transthyretin-mediated amyloidosis, a rare disease caused by variants in the transthyretin gene that results in high mortality, and stage 1 or 2 polyneuropathy, the simultaneous malfunction of many peripheral nerves throughout the body.
The committee adopted positive opinions for Absimky (ustekinumab) and Imuldosa (ustekinumab), two biosimilar medicines intended for the treatment of paediatric plaque psoriasis, and adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease or ulcerative colitis.
The committee recommended granting a marketing authorisation for Buprenorphine Neuraxpharm (buprenorphine), a substitution treatment of opioid drug dependence. This medicine was submitted as a hybrid application, which relies in part on the results of pre-clinical tests and clinical trials of an already-authorised reference product, and in part on new data.
The committee also recommended granting a marketing authorisation for Eltrombopag Viatris (eltrombopag), a generic medicine for the treatment of children and adults with primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C.
Recommendations on extensions of therapeutic indication for six medicines
The committee recommended extensions of indication for six medicines that are already authorised in the EU: Cerdelga* (eliglustat), Hepcludex* (bulevirtide), Kevzara (sarilumab), Kisqali (ribociclib), Tevimbra (tislelizumab) and Yselty (linzagolix choline).
Withdrawal of applications
Two applications for marketing authorisation were withdrawn: Apremilast Viatris (apremilast), a medicine for the treatment of plaque psoriasis, active psoriatic arthritis and mouth ulcers caused by Behçet’s disease, and Epixram (levetiracetam), for the treatment of seizures in patients with epilepsy.
Question-and-answer documents on the withdrawals of these medicines are available in the grid below.
Outcome of re-examination
Following a re-examination, the CHMP confirmed its initial recommendation to refuse the granting of a conditional marketing authorisation for Masitinib AB Science* (masitinib). This medicine was intended for the treatment of amyotrophic lateral sclerosis (ALS), a progressive disease of the nervous system, where nerve cells in the brain and spinal cord that control voluntary movement gradually deteriorate, causing loss of muscle function and paralysis.
For more information on the refusal of this marketing authorisation, see the question-and-answer document in the grid below.
The committee also confirmed its previous recommendation to not renew the conditional marketing authorisation for Translarna (ataluren). This last round of assessment concluded that the effectiveness of Translarna has not been confirmed. This medicine is used for treating patients with Duchenne muscular dystrophy aged 2 years and older who are able to walk and whose disease is caused by a type of genetic defect called a ‘nonsense mutation’ in the dystrophin gene.
For more information on the non-renewal of this conditional marketing authorisation, see the public health communication in the grid below.
Other updates
The CHMP gave positive opinions to update the composition of Nuvaxovid1,a vaccine to target the SARS-CoV-2 JN.1 variant of the virus that causes COVID-19, and Bimervax, a vaccine targeting the Omicron XBB.1.16 subvariant. The revision of Nuvaxovid follows the recommendations issued by EMA’s Emergency Task Force to update COVID-19 vaccines for the 2024/2025 vaccination campaign, while the approval of Bimervax indicates the ability to update the vaccine composition in view of further updates.
Election of new vice-chair
The Committee for Human Medicinal Products (CHMP) elected Outi Mäki-Ikola as its new vice-chair for a three-year mandate, starting on 15 October 2024. A medical doctor by training, with a PhD in immunology, Dr Mäki-Ikola has prior work experience in medicine development. She has also worked at EMA as a Scientific Administrator from 2004 to 2009. Since 2012, she has been a Senior Medical Officer at the Finnish Medicines Agency (Fimea) and a member of the CHMP representing Finland.
Agenda and minutes
The agenda of the October 2024 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
CHMP statistics
Key figures from the October 2024 meeting are represented in the graphic below.
*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.
1 CHMP opinion adopted on 7 October 2024
Positive recommendations on new medicines
Alhemo
- International non-proprietary name (INN)
Concizumab
- Marketing authorisation applicant
Novo Nordisk A/S
- Therapeutic indication
Routine prophylaxis of bleeding in patients with; haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors and of 12 years of age or more; haemophilia B (congenital factor IX deficiency) with FIX inhibitors and of 12 years of age or more.
- More information
Fluad
- INN
Influenza vaccine (surface antigen, inactivated, adjuvanted)
- Marketing authorisation applicant
Seqirus Netherlands B.V.
- Therapeutic indication
Prophylaxis of influenza in adults 50 years of age and older
- More information
Flucelvax
- INN
Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
- Marketing authorisation applicant
Seqirus Netherlands B.V.
- Therapeutic indication
Prophylaxis of influenza in adults and children from 2 years of age
- More information
Korjuny
- INN
Catumaxomab
- Marketing authorisation applicant
Lindis Biotech GmbH
- Therapeutic indication
indicated for the treatment of malignant ascites
- More information
Siiltibcy
- INN
Mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10)
- Marketing authorisaton applicant
Serum Life Science Europe GmbH
- Therapeutic indication
Diagnosis of infection with Mycobacterium tuberculosis
- More information
Wainzua
- INN
Eplontersen
- Marketing authorisaton applicant
AstraZeneca AB
- Therapeutic indication
Treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with stage 1 or stage 2 polyneuropathy
- More information
Positive recommendations on new biosimilar medicines
Absimky
- INN
Ustekinumab
- Marketing authorisation applicant
Accord Healthcare
- Therapeutic indication
Treatment of active plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease and ulcerative colitis
- More information
Imuldosa
- INN
Ustekinumab
- Marketing authorisation applicant
Accord Healthcare S.L.U.
- Therapeutic indication
Treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis (PsA), Crohn’s disease
- More information
Positive recommendation on new hybrid medicine
Buprenorphine Neuraxpharm
- INN
Buprenorphine
- Marketing authorisation applicant
Neuraxpharm Pharmaceuticals S.L.
- Therapeutic indication
Treatment of opioid drug dependence
- More information
Positive recommendation on new generic medicine
Eltrombopag Viatris
- INN
Eltrombopag
- Marketing authorisation applicant
Viatris Limited
- Therapeutic indication
Treatment of primary immune thrombocytopenia (ITP), chronic hepatitis C virus (HCV) and acquired severe aplastic anaemia (SAA)
- More information
Positive recommendations on extensions of therapeutic indications
Cerdelga
- INN
Eliglusta
- Marketing authorisation holder
Sanofi B.V.
- More information
Hepcludex
- INN
Bulevirtide
- Marketing authorisation holder
Gilead Sciences Ireland UC
- More information
Kevzara
- INN
Sarilumab
- Marketing authorisation holder
Sanofi Winthrop Industrie
- More information
Kisqali
- INN
Ribociclib
- Marketing authorisation holder
Novartis Europharm Limited
- More information
Tevimbra
- INN
Tislelizumab
- Marketing authorisation holder
BeiGene Ireland Ltd
- More information
Yselty
- INN
Linzagolix choline
- Marketing authorisation holder
Theramex Ireland Limited
- More information
Apremilast Viatris
- INN
Apremilast
- Marketing authorisation applicant
Viatris Limited
- More information
Epixram
- INN
Levetiracetam
- Marketing authorisation applicant
Neuraxpharm Pharmaceuticals S.L.
- More information
Outcome of re-examination
Masitinib AB Science
- INN
Masitinib
- Marketing authorisation holder
AB Science
- More information
Translarna
- INN
ataluren
- Marketing authorisation holder
PTC Therapeutics International Limited
- More information