EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its June 2024 meeting.
The committee recommended granting a marketing authorisation for Balversa (erdafitinib), for the treatment of adult patients with unresectable or metastatic urothelial carcinoma, a cancer of the bladder and urinary system.
The CHMP adopted a positive opinion for Eurneffy (epinephrine), the first emergency treatment against allergic reactions that is administered as a nasal spray, not as an injection. See more details in the news announcement in the grid below.
mResvia (Respiratory Syncytial Virus (RSV) mRNA vaccine) received a positive opinion from the CHMP for prevention in adults 60 years of age and older of lower respiratory tract disease and acute respiratory disease caused by respiratory syncytial virus, a common respiratory virus that usually causes mild, cold-like symptoms but can lead to serious consequences in older adults. This is the first mRNA vaccine targeting a different pathogen than SARS-CoV-2 that receives a positive opinion from the CHMP.
The committee recommended granting a conditional marketing authorisation for Ordspono* (odronextamab), for the treatment of follicular lymphoma and diffuse large B-cell lymphoma, two types of blood cancer that affect the immune system.
Piasky (crovalimab) received a positive opinion from the CHMP for the treatment of paroxysmal nocturnal haemoglobinuria, a rare genetic disorder that causes the premature breakdown of red blood cells by the immune system and is potentially life-threatening.
The CHMP gave a positive opinion for Tauvid (flortaucipir (18F)), for positron emission tomography (PET) imaging of the brain in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease.
The CHMP recommended granting a marketing authorisation for Winrevair* (sotatercept), to treat adult patients with pulmonary arterial hypertension, a rare, long-term, debilitating and life-threatening condition in which patients have abnormally high blood pressure in the arteries in the lungs. This medicine was supported through EMA’s Priority Medicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with a potential to address unmet medical needs. See more details in the news announcement in the grid below.
The committee recommended granting a marketing authorisation for Steqeyma (ustekinumab), a biosimilar medicine for the treatment of adult patients with moderately-to severely-active Crohn’s disease, plaque psoriasis, paediatric plaque psoriasis and psoriatic arthritis.
The committee also adopted positive opinions for two generic medicines:
The CHMP recommended the refusal of marketing authorisations for Masitinib AB Science* (masitinib), a medicine intended for the treatment of amyotrophic lateral sclerosis, a rare disease of the nervous system leading to loss of muscle function and paralysis, and Syfovre (pegcetacoplan), for the treatment of geographic atrophy secondary to age-related macular degeneration, a progressive retinal macular disease causing gradual vision impairment mainly in elderly people.
For more information on these negative opinions, see the question-and-answer documents in the grid below.
The committee recommended not renewing the conditional marketing authorisation for Translarna* (ataluren), a medicine for treating patients with non-sense mutation Duchenne muscular dystrophy, a genetic disorder characterised by the progressive loss of muscle. This CHMP opinion will now be forwarded to the European Commission for a final legally-binding decision applicable in all European Union (EU) Member States.
For more information on the non-renewal of this conditional marketing authorisation, see the public health communication in the grid below.
Recommendations on extensions of therapeutic indication for 11 medicines
The committee recommended extensions of indication for 11 medicines that are already authorised in the EU: Betmiga, Beyfortus, Cresemba, Imcivree*, Imfinzi, Infanrix hexa, Lynparza, Pegasys, Tepkinly*, Vabysmo and Xalkori.
One application for an initial marketing authorisation was withdrawn. Dabigatran etexilate Teva (dabigatran etexilate) was intended for the prevention of venous thromboembolic events.
A question-and-answer document on the withdrawal of Dabigatran Teva is available in the grid below.
The committee completed a review of Havrix, a vaccine used to protect adults and children against hepatitis A virus infection, and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU. A question-and-answer document is available in the grid below.
The CHMP completed a review of Lorazepam Macure, a medicine of the benzodiazepine class, following disagreement among EU Member States about an application to update the medicine’s product information to include the control of status epilepticus in adults, adolescents and children from one month old. A question-and-answer document about this update is available in the grid below.
EMA’s human medicines committee concluded its review of Ocaliva*, a medicine used to treat adults with a rare liver disease known as primary biliary cholangitis, and recommended that the medicine’s conditional marketing authorisation should be revoked because its benefits are no longer considered to outweigh its risks. For more information on the recommendation to revoke this conditional marketing authorisation see the public health communication in the grid below.
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 of the virus that causes COVID-19. The revision of this vaccine is in line with the recommendation issued by EMA’s Emergency Task Force to update COVID-19 vaccines to target the SARS-CoV-2 variant JN.1 for the 2024/2025 vaccination campaign.
The agenda of the June 2024 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
Key figures from the June 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.
erdafitinib
Janssen-Cilag International N.V.
Treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma
epinephrine
Ars Pharmaceuticals Irl Limited
Treatment of allergic reactions (anaphylaxis) and idiopathic or exercise induced anaphylaxis
Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation
Moderna Biotech Spain S.L.
Prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older
odronextamab
Regeneron Ireland Designated Activity Company
Treatment of blood cancers (follicular lymphoma (FL) or diffuse large B cell lymphoma (DLBCL) and large B cell lymphoma)
crovalimab
Roche Registration GmbH
Treatment of paroxysmal nocturnal haemoglobinuria
Flortaucipir (18F)
Eli Lilly Nederland B.V.
Indicated for Positron Emission Tomography (PET) imaging of the brain
sotatercept
Merck Sharp & Dohme B.V.
Treatment of pulmonary arterial hypertension in adults
ustekinumab
Celltrion Healthcare Hungary Kft.
Treatment of adult patients with moderately to severely active Crohn’s disease, plaque psoriasis, paediatric plaque psoriasis and Psoriatic arthritis (PsA)
enzalutamide
Viatris Limited
Treatment of prostate cancer
nilotinib
Accord Healthcare S.L.U.
Treatment of Philadelphia chromosome positive chronic myelogenous leukaemia (CML)
masitinib
AB Science
In combination with riluzole for the treatment of adult patients with amyotrophic lateral sclerosis (ALS)
pegcetacoplan
Apellis Europe B.V.
Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
ataluren
PTC Therapeutics International Limited
mirabegron
Astellas Pharma Europe B.V.
nirsevimab
Sanofi Winthrop Industrie
isavuconazole
Basilea Pharmaceutica Deutschland GmbH
setmelanotide
Rhythm Pharmaceuticals Netherlands B.V.
durvalumab
AstraZeneca AB
diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inact.) and haemophilus type B conjugate vaccine (adsorbed)
GlaxoSmithkline Biologicals SA
olaparib
AstraZeneca AB
peginterferon alfa-2a
Pharmaand GmbH
epcoritamab
AbbVie Deutschland GmbH & Co. KG
faricimab
Roche Registration GmbH
crizotinib
Pfizer Europe MA EEIG
dabigatran etexilate
TEVA GmbH
Hepatitis A virus (inactivated, adsorbed)
GlaxoSmithKline Biologicals
lorazepam
Macure Pharma ApS
obeticholic acid
Advanz Pharma Limited