CHMP’s September 2023 meeting highlights

The European Medicines Agency (EMA)’s human medicines committee (CHMP) recommended nine new medicines for approval during its meeting in September 2023.

The committee recommended granting a marketing authorisation for Ebglyss (lebrikizumab). This medicine is indicated for treating moderate-to-severe atopic dermatitis in adults and adolescents.

To treat glioma, a type of brain tumour, the CHMP gave a positive opinion for Finlee (dabrafenib).

The committee gave a positive opinion for Vanflyta (quizartinib), a medicine for adults with acute myeloid leukaemia.

Parathyroid hormone replacement therapy Yorvipath (palopegteriparatide), was granted a positive opinion in chronic hypoparathyroidism.

The committee granted a positive opinion for Zilbrysq (zilucoplan) for the treatment of generalised myasthenia gravis.

A marketing authorisation was recommended for Zoonotic Influenza Vaccine Seqirus (surface antigen, inactivated, adjuvanted), for active immunisation against H5N1 subtype of Influenza A virus.

Biosimilar medicine Herwenda (trastuzumab) for metastatic and early breast cancer and metastatic gastric cancer was given a positive opinion by the CHMP.

Additionally, the committee recommended a paediatric-use marketing authorisation (PUMA) for Aqumeldi (enalapril maleate) for heart failure. It also recommended giving a marketing authorisation for Catiolanze (latanoprost) as a medicine to reduce elevated intraocular pressure.

CHMP’s recommended extensions of therapeutic indications

The committee recommended 11 indication extensions for authorised medicines in the EU: Adcetris, Enhertu, Kaftrio, Kalydeco, Keytruda, Nordimet, Olumiant, Pepaxti, Ryeqo, Takhzyro and Voxzogo.

Non-renewal of conditional marketing authorisations

The committee recommended not renewing the conditional marketing authorisation of Translarna (ataluren), indicated for Duchenne muscular dystrophy and BlenRep (belantamab mafodotin) a multiple myeloma treatment.

Moreover, the CHMP recommended authorisation of two adapted vaccines targeting the Omicron XBB.1.5 subvariant. This adapted Comirnaty vaccine received a positive opinion on 30 August 2023. The adapted Spikevax vaccine was recommended for authorisation too.

Start of referral

In its September 2023 meeting, the CHMP also started the referral procedure for Havrix (inactivated, adsorbed), a vaccine protecting against infections caused by hepatitis A virus. The goal of the process is to harmonise the prescribing information across the countries where the product is approved, following several inconsistencies being identified.

The CHMP began to review the benefits and risks of Mysimba (naltrexone/bupropion), a medicine used as a weight management tool in conjunction with diet and exercise for adults.