EMA’s human medicines committee (CHMP) recommended seventeen medicines for approval at its December 2024 meeting. This brings the total number of medicines recommended for approval in 2024 to 114.
The CHMP recommended granting a marketing authorisation for Andembry* (garadacimab), for the prevention of recurrent attacks of hereditary angioedema, a rare, potentially life-threatening disorder characterised by attacks of cutaneous and submucosal swelling.
The committee adopted a positive opinion for Beyonttra* (acoramidis), for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy, a disease that affects the heart muscle.
Kavigale (sipavibart), a monoclonal antibody intended for the prevention of COVID-19 in immunocompromised people aged 12 years and older, received a positive opinion from the CHMP. Additional information on the level of activity of anti-spike protein monoclonal antibodies against emerging SARS-CoV-2 variants is also available below.
The CHMP recommended granting a marketing authorisation for Kostaive (zapomeran), a self-amplifying mRNA vaccine intended for the prevention of COVID-19 in individuals 18 years of age and older.
Nemluvio (nemolizumab) received a positive opinion from the CHMP for the treatment of atopic dermatitis, a chronic skin disease, and prurigo nodularis, an under-recognised inflammatory skin condition.
Rytelo* (imetelstat) received a positive opinion for the treatment of adult patients with transfusion-dependent anaemia due to very low, low or intermediate risk myelodysplastic syndromes, when the bone marrow does not make enough healthy blood cells or platelets.
The committee recommended granting a conditional marketing authorisation for Seladelpar Gilead* (seladelpar lysine dihydrate), for the treatment of primary biliary cholangitis, an autoimmune liver disease. 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.
The CHMP recommended granting a conditional marketing authorisation for Welireg (belzutifan), for the treatment of tumours associated with von Hippel-Lindau disease and advanced clear cell renal cell carcinoma. This is the first medicine to treat von Hippel-Lindau disease, a rare genetic disorder causing cysts and tumours. See more details in the news announcement in the grid below.
The CHMP recommended granting a marketing authorisation for three hybrid applications, which rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data:
The committee adopted positive opinions for six biosimilar medicines:
The CHMP recommended extending the indication of Ofev for the treatment of progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents from the age of six. Currently there are no approved therapies for these conditions in children. Fibrosing ILDs encompass a group of rare, complex and heterogeneous respiratory disorders that can be linked to many causes, including growth abnormalities or autoimmune conditions like rheumatoid arthritis. See more details in the news announcement in the grid below.
The committee recommended additional extensions of indication for seven medicines that are already authorised in the EU: Blincyto*, Bridion, Flucelvax Tetra, Jemperli, Omvoh, Rekambys and Vocabria.
The applicants for Cinainu and Kizfizo* requested a re-examination of EMA’s November 2024 opinion not to grant a marketing authorisation. The marketing authorisation holder for Keytruda requested a re-examination of EMA’s November 2024 opinion.
Upon receipt of the grounds of these requests, the Agency will re-examine its opinions and issue final recommendations.
Following the recommendation for approval of Kavigale, EMA’s Emergency Task Force (ETF) has issued an updated statement on the loss of activity of anti-spike protein monoclonal antibodies due to emerging SARS-CoV-2 variants and recommends healthcare professionals to check the current epidemiological situation in their region. See more details in the statement in the grid below.
Data from a recent study have shown that Alofisel (darvadstrocel), a medicine used to treat complex anal fistulas (abnormal passages between the lower parts of the gut and the skin near the anus) in adults with Crohn’s disease, does not work well enough. As the company that markets Alofisel considered that it was not possible for them to provide additional data on the effectiveness of the medicine as expected by EMA, it has decided to withdraw the medicine from the EU market. For more information, see public health communication in the grid below.
The CHMP has finalised its assessment of an application to extend the use of Mounjaro (tirzepatide) to include the treatment of obstructive sleep apnoea (OSA) in adults with obesity. Mounjaro is a medicine used together with diet and physical activity to treat adults with type 2 diabetes which is not satisfactorily controlled. It is also used together with diet and physical activity to help people with obesity (BMI of 30 kg/m2 or more) or who are overweight (BMI between 27 and 30 kg/m2) and who have weight-related health problems lose weight and keep their weight under control. The CHMP considered that the use of Mounjaro in this group of people is already covered by the approved indication for weight management and that a separate indication for the treatment of moderate to severe OSA in adults with obesity is not needed. For more information on the CHMP opinion for this medicine, see the question-and-answer document in the grid below.
The agenda of the December 2024 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
Key figures from the December 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.
garadacimab
CSL Behring GmbH
Routine prevention of attacks of hereditary angioedema (HAE)
acoramidis
BridgeBio Europe B.V.
Treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM)
sipavibart
AstraZeneca AB
Indicated for the pre-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older
zapomeran
Arcturus Therapeutics Europe B.V.
Active immunisation to prevent COVID-19 in individuals 18 years of age and older
nemolizumab
Galderma International
Treatment of moderate-to-severe atopic dermatitis and for the treatment of prurigo nodularis
imetelstat
Geron Netherlands B.V.
Treatment of transfusion-dependent anaemia in adults with low- to intermediate-1 risk
seladelpar lysine dihydrate
CymaBay Ireland, Ltd
Treatment of primary biliary cholangitis (PBC) including pruritus in adults without cirrhosis or with compensated cirrhosis (Child-Pugh A) in combination with ursodeoxycholic acid (UDCA) who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA
belzutifan
Merck Sharp & Dohme B.V.
Treatment of adult patients with advanced renal cell carcinoma (RCC) and treatment of adult patients with von Hippel-Lindau (VHL) disease
tocilizumab
Celltrion Healthcare Hungary Kft.
Treatment of rheumatoid arthritis
aflibercept
Celltrion Healthcare Hungary Kft.
Treatment of age-related macular degeneration (AMD) and visual impairment
denosumab
Celltrion Healthcare Hungary Kft.
Prevention of skeletal related events with advanced malignancies
denosumab
Celltrion Healthcare Hungary Kft.
Treatment of osteoporosis and bone loss
ustekinumab
Biosimilar Collaborations Ireland Limited
Treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis, Crohn's disease
filgrastim
CuraTeQ Biologics s.r.o.
Reduction in the duration of neutropenia and the incidence of febrile neutropenia
tiratricol
Rare Thyroid Therapeutics International AB
Treatment of monocarboxylate transporter 8 (MCT8) deficiency
guanfacine
Neuraxpharm Pharmaceuticals S.L.
Treatment of ADHD
methylphenidate hydrochloride
Neuraxpharm Pharmaceuticals S.L.
Treatment of attention deficit hyperactivity disorder in children aged 6 years of age and over
blinatumomab
Amgen Europe B.V.
sugammadex
Merck Sharp & Dohme B.V.
influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Seqirus Netherlands B.V.
dostarlimab
GlaxoSmithKline (Ireland) Limited
nintedanib
Boehringer Ingelheim International GmbH
mirikizumab
Eli Lilly Nederland B.V.
rilpivirine
Janssen-Cilag International NV
cabotegravir
ViiV Healthcare B.V.
liquid ethanolic extract 30 per cent (W/W) of allium cepa fresh bulb and citrus limon fresh fruit / dry aqueous extract of paullinia cupana seed / dry hydroethanolic extract of theobroma cacao seed
Legacy Healthcare (France) S.A.S.
Treatment of alopecia areata in children and adolescents
Cinainu: pending EC decision (to be published shortly)
temozolomide
Orphelia Pharma
Treatment of neuroblastoma
pembrolizumab
Merck Sharp & Dohme B.V.
Keytruda: pending EC decision (to be published shortly)