Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.
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Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.
The CHMP recommended granting a marketing authorisation for Altuvoct* (efanesoctocog alfa), for the treatment and prophylaxis of bleeding in patients with haemophilia A, a rare inherited bleeding disorder caused by lack of factor VIII.
The committee adopted a positive opinion for Fruzaqla (fruquintinib), indicated for the treatment of patients with previously treated metastatic colorectal cancer.
The CHMP gave a positive opinion for Jeraygo (aprocitentan), for the treatment of resistant hypertension.
Obgemsa (vibegron) received a positive opinion for the treatment of adults with overactive bladder syndrome.
The CHMP gave a positive opinion for Truqap (capivasertib), for the treatment of locally advanced or metastatic breast cancer with one or more specific mutations.
The committee adopted positive opinions for two biosimilar medicines:
- Tofidence (tocilizumab), for the treatment of rheumatoid arthritis, COVID-19, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
- Wezenla (ustekinumab), for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease.
A positive opinion was adopted for Eribulin Baxter (eribulin), a generic medicine indicated for the treatment of breast cancer and liposarcoma, a rare cancer that develops in fatty tissue.
Withdrawals of applications
Two applications for marketing authorisation were withdrawn: GeGant, a radionuclide generator which can be used by doctors to label diagnostic medicines, and Upstelda, a biosimilar for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease. Upstelda is a duplicate of Wezenla.
A question-and-answer document on the withdrawal of GeGant is available in the grid below.
Recommendations on extensions of therapeutic indication for six medicines
The committee recommended extensions of indication for six medicines that are already authorised in the European Union (EU): Alecensa, Opdivo, Rozlytrek, Rybrevant, Sirturo and Triumeq.
Other updates
The CHMP recommended new contraindications on the co-administration of Reyataz (Atazanavir) with encorafenib and ivosidenib, and with carbamazepine, phenobarbital, and phenytoin.
Regulatory updates
Following the appellate judgment of the Court of Justice of 14 March 2024 in Case C-291/22 P), EMA is currently considering the impact of the appellate judgment on the evaluation of Hopveus, which was the subject of the court case, as well as other regulatory procedures. On these grounds, the CHMP has decided to convene a new ad-hoc expert group (AHEG) for Syfovre and reset the evaluation procedure for this medicine from that point to day 180 of the initial assessment procedure.
The appellate judgment examined questions related to the organisation of EMA’s Scientific Advisory Groups (SAGs) and ad-hoc expert groups (AHEGs). SAGs and AHEGs are groups of scientific experts that are called upon to respond to specific questions posed by EMA’s committees during the evaluation of a medicine.
EMA is also currently considering the impact of the appellate judgment on the evaluation of other regulatory procedures and will further communicate as appropriate.
Agenda and minutes
The agenda of the April 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 April 2024 CHMP 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.
Positive recommendations on new medicines
Altuvoct
- International non-proprietary name (INN)
efanesoctocog alfa
- Marketing-authorisation applicant
Swedish Orphan Biovitrum AB (publ)
- Therapeutic indication
Treatment and prophylaxis of bleeding in patients with haemophilia A.
- More information
Fruzaqla
- International non-proprietary name (INN)
fruquintinib
- Marketing-authorisation applicant
Takeda Pharmaceuticals International AG Ireland Branch
- Therapeutic indication
Treatment of metastatic colorectal cancer.
- More information
Jeraygo
- INN
aprocitentan
- Marketing-authorisation applicant
Idorsia Pharmaceuticals Deutschland GmbH
- Therapeutic indication
Treatment of resistant hypertension.
- More information
Obgemsa
- INN
vibegron
- Marketing-authorisation applicant
Pierre Fabre Medicament
- Therapeutic indication
Treatment of micturition frequency and/or urgency incontinence as may occur in adult patients with Over Active Bladder (OAB) syndrome.
- More information
Truqap
- INN
capivasertib
- Marketing-authorisation applicant
AstraZeneca AB
- Therapeutic indication
Indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2 negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.
- More information
Positive recommendation on new biosimilar medicines
Tofidence
- INN
tocilizumab
- Marketing-authorisation applicant
Biogen Netherlands B.V.
- Therapeutic indication
Treatment of rheumatoid arthritis (RA), coronavirus disease 2019 (COVID-19), polyarticular juvenile idiopathic arthritis (pJIA), and systemic juvenile idiopathic arthritis (sJIA).
- More information
Wezenla
- INN
ustekinumab
- Marketing-authorisation applicant
Amgen Technology (Ireland) Unlimited Company
- Therapeutic indication
Treatment of moderate to severe plaque psoriasis in adults, children and adolescents, active psoriatic arthritis in adults and Crohn’s Disease.
- More information
Positive recommendation on new generic medicine
Eribulin Baxter
- INN
eribulin
- Marketing-authorisation applicant
Baxter Holding B.V.
- Therapeutic indication
Treatment of breast cancer and liposarcoma.
- More information
Positive recommendations on extensions of indications
Alecensa
- INN
alectinib
- Marketing-authorisation holder
Roche Registration GmbH
- More information
Opdivo
- INN
nivolumab
- Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
- More information
Rozlytrek
- INN
entrectinib
- Marketing-authorisation holder
Roche Registration GmbH
- More information
Rybrevant
- INN
amivantamab
- Marketing-authorisation holder
Janssen-Cilag International N.V.
- More information
Sirturo
- INN
bedaquiline
- Marketing-authorisation holder
Janssen-Cilag International N.V.
- More information
Triumeq
- INN
dolutegravir / abacavir / lamivudine
- Marketing-authorisation holder
ViiV Healthcare B.V.
- More information
Recommendation on new contraindication
Reyataz
- INN
atazanavir sulfate
- Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
- More information
GeGant
- INN
germanium (68Ge) chloride / gallium (68Ga) chloride
- Marketing-authorisation applicant
ITM Medical Isotopes GmbH
- More information