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:
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.
Two applications for marketing authorisation were withdrawn: GeGant, a radionuclide generator which can be used by doctors to label diagnostic medicines, and Upstelda, a biosimilar for the treatment of plaque psoriasis,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.
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.
The CHMP recommended new contraindications on the co-administration of Reyataz (Atazanavir) with encorafenib and ivosidenib, and with carbamazepine, phenobarbital, and phenytoin.
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.
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.
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.
efanesoctocog alfa
Swedish Orphan Biovitrum AB (publ)
Treatment and prophylaxis of bleeding in patients with haemophilia A.
fruquintinib
Takeda Pharmaceuticals International AG Ireland Branch
Treatment of metastatic colorectal cancer.
aprocitentan
Idorsia Pharmaceuticals Deutschland GmbH
Treatment of resistant hypertension.
vibegron
Pierre Fabre Medicament
Treatment of micturition frequency and/or urgency incontinence as may occur in adult patients with Over Active Bladder (OAB) syndrome.
capivasertib
AstraZeneca AB
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.
tocilizumab
Biogen Netherlands B.V.
Treatment of rheumatoid arthritis (RA), coronavirus disease 2019 (COVID-19), polyarticular juvenile idiopathic arthritis (pJIA), and systemic juvenile idiopathic arthritis (sJIA).
ustekinumab
Amgen Technology (Ireland) Unlimited Company
Treatment of moderate to severe plaque psoriasis in adults, children and adolescents, active psoriatic arthritis in adults and Crohn’s Disease.
eribulin
Baxter Holding B.V.
Treatment of breast cancer and liposarcoma.
alectinib
Roche Registration GmbH
nivolumab
Bristol-Myers Squibb Pharma EEIG
entrectinib
Roche Registration GmbH
amivantamab
Janssen-Cilag International N.V.
bedaquiline
Janssen-Cilag International N.V.
dolutegravir / abacavir / lamivudine
ViiV Healthcare B.V.
atazanavir sulfate
Bristol-Myers Squibb Pharma EEIG
germanium (68Ge) chloride / gallium (68Ga) chloride
ITM Medical Isotopes GmbH