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Medicines Recommended for Approval by EMA CHMP at June 2024 Meeting

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The European Medicines Agency’s (EMA) Human Medicines Committee (CHMP) recommended ten medicines for approval at its June 2024 meeting. The committee recommended granting marketing authorization for Balversa (erdafitinib) for treating adult patients with unresectable or metastatic urothelial carcinoma, a cancer of the bladder and urinary system. Additionally, Eurneffy (epinephrine), the first emergency treatment against allergic reactions administered as a nasal spray, received a positive opinion from the CHMP.

mResvia, an mRNA vaccine for Respiratory Syncytial Virus (RSV), received a positive opinion for prevention in adults aged 60 and older of lower respiratory tract disease and acute respiratory disease caused by RSV. This marks the first mRNA vaccine targeting a pathogen other than SARS-CoV-2 to receive a positive opinion from the CHMP.

Ordspono (odronextamab) was recommended for conditional marketing authorization for treating follicular lymphoma and diffuse large B-cell lymphoma, two types of blood cancer that affect the immune system. Piasky (crovalimab) also received a positive opinion for treating paroxysmal nocturnal hemoglobinuria, a rare genetic disorder causing the premature breakdown of red blood cells and is potentially life-threatening.

Medicines for Alzheimer’s, Hypertension, and Crohn’s Disease Recommended

Tauvid (flortaucipir (18F)) was recommended for positron emission tomography (PET) imaging of the brain in adult patients with cognitive impairment being evaluated for Alzheimer’s disease. Winrevair (sotatercept) was recommended for treating adult patients with pulmonary arterial hypertension, a severe condition causing high blood pressure in the arteries of the lungs. This medicine was supported through EMA’s Priority Medicines (PRIME) scheme.

Steqeyma (ustekinumab), a biosimilar medicine, was recommended for treating adult patients with moderately to severely active Crohn’s disease, plaque psoriasis, pediatric plaque psoriasis, and psoriatic arthritis. The committee also adopted positive opinions for two generic medicines: Enzalutamide Viatris (enzalutamide) for treating prostate cancer, and Nilotinib Accord (nilotinib) for treating Philadelphia chromosome-positive chronic myelogenous leukemia.

The CHMP recommended refusing marketing authorizations for Masitinib AB Science (masitinib), intended for treating amyotrophic lateral sclerosis, and Syfovre (pegcetacoplan), intended for treating geographic atrophy secondary to age-related macular degeneration. Details on these negative opinions can be found in the question-and-answer documents. The committee also recommended not renewing the conditional marketing authorization for Translarna (ataluren) for treating nonsense mutation Duchenne muscular dystrophy.

Medicines

EMA CHMP June 2024 Recommendations Forwarded to European Commission for Final Decision

This opinion will be forwarded to the European Commission for a final decision. The CHMP recommended extensions of indication for 11 medicines already authorized in the EU: Betmiga, Beyfortus, Cresemba, Imcivree, Imfinzi, Infanrix hexa, Lynparza, Pegasys, Tepkinly, Vabysmo, and Xalkori. One application for initial marketing authorization for Dabigatran etexilate Teva was withdrawn. The CHMP completed a review of Havrix, a vaccine against hepatitis A, and recommended harmonizing its prescribing information.

A review of Lorazepam Macure, following disagreement among EU Member States, led to an update in the product information to include control of status epilepticus in adults, adolescents, and children from one month old. The CHMP concluded its review of Ocaliva, used to treat primary biliary cholangitis, and recommended revoking its conditional marketing authorization due to an unfavorable benefit-risk balance.

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The CHMP gave a positive opinion to update the composition of the mRNA vaccine Comirnaty to target the new SARS-CoV-2 JN.1 variant for the 2024/2025 vaccination campaign. The agenda of the June 2024 CHMP meeting is published on EMA’s website, with minutes to be published in the coming weeks. Key figures from the June 2024 CHMP meeting are represented in the graphic below.

 

Resource: European Medicines Agency, June 28, 2024

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