At its recent June meeting, the EMA’s human medicines committee (CHMP) recommended 10 medicines for approval.
Recommendations for regulatory approval
The committee saw a need to give a marketing authorisation to Balversa (erdafitinib) as a treatment for adults with unresectable or metastatic urothelial carcinoma.
In its meeting, the CHMP gave a positive opinion for the first nasally administered emergency treatment for allergic reactions. Eurneffy (epinephrine) offers an alternative method to the standard injection method of administration.
the CHMP gave a positive opinion for the first nasally administered emergency treatment for allergic reactions”
A positive opinion was granted to the mResvia (Respiratory Syncytial Virus (RSV) mRNA vaccine). It was recommended for the prevention of lower respiratory tract disease and acute respiratory disease caused by respiratory syncytial virus in adults 60 years of age and over.
The CHMP gave a positive opinion to update the composition of the COVID-19 mRNA vaccine Comirnaty to target the new SARS-CoV-2 JN.1 virus variant.
The regulatory group recommended conditional approval of Ordspono (odronextamab), for follicular lymphoma and diffuse large B-cell lymphoma.
Piasky (crovalimab) was recommended for paroxysmal nocturnal haemoglobinuria and Winrevair (sotatercept) for pulmonary arterial hypertension in adults.
The committee gave a positive opinion for the biosimilar Steqeyma (ustekinumab). The treatment is intended for adults with moderately-to severely-active Crohn’s disease, plaque psoriasis, paediatric plaque psoriasis and psoriatic arthritis, according to the CHMP.
Additionally, approval was recommended two generic medicines: Enzalutamide Viatris (enzalutamide) to treat prostate cancer, and Nilotinib Accord (nilotinib) was also recommended to treat Philadelphia chromosome positive chronic myelogenous leukaemia.
CHMP’s negative opinions
Conversely, the CHMP recommended against authorising two medicines:
- Masitinib AB Science (masitinib), for the rare disease amyotrophic lateral sclerosis
- Syfovre (pegcetacoplan) for geographic atrophy secondary to age-related macular degeneration.
The organisation also gave a negative opinion for the renewal of conditional marketing authorisation for Translarna (ataluren), for non-sense mutation Duchenne muscular dystrophy.
Furthermore, the committee recommended extending indication for: Betmiga, Beyfortus, Cresemba, Imcivree, Imfinzi, Infanrix hexa, Lynparza, Pegasys, Tepkinly, Vabysmo and Xalkori.
Further decisions made by CHMP
A marketing authorisation application was withdrawn for Dabigatran etexilate Teva (dabigatran etexilate), indicated to prevent venous thromboembolic events.
EMA’s human medicines committee decided to revoke the conditional marketing authorisation for Ocaliva. This medicine is intended for adults who have primary biliary cholangitis, a rare liver disease.
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