Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024

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Two applications for marketing authorisation were withdrawn: GeGant, a radionuclide generator which can be used by doctors to label diagnostic medicines, and Upstelda, a biosimilar for the treatment of plaque psoriasis,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.

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*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.