EMA approves 17 medicines at December meeting

The European Medicines Agency rounded off a busy year by approving seventeen new medicines. At its December meeting, the Committee for Medicinal Products for Human Use (CHMP) also extended the therapeutic indications of another eight products which had already been approved for other conditions.

The new products given the green light included:

• 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.
• 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.
• Kostaive (zapomeran), a self-amplifying mRNA vaccine intended for the prevention of COVID-19 in individuals 18 years of age and older.
• Nemluvio (nemolizumab) for the treatment of atopic dermatitis, a chronic skin disease, and prurigo nodularis, an under-recognised inflammatory skin condition.
• Rytelo (imetelstat) 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.
• Seladelpar Gilead (seladelpar lysine dihydrate) for the treatment of primary biliary cholangitis, an autoimmune liver disease.
• Welireg (belzutifan) for the treatment of tumours associated with von Hippel-Lindau disease and advanced clear cell renal cell carcinoma.
• Emcitate (tiratricol) the first treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome, an ultra-rare, chronic and severely debilitating disease.
• Paxneury (guanfacine) for the treatment of attention-deficit hyperactivity disorder in children.
• Tuzulby (methylphenidate hydrochloride) a paediatric-use marketing authorisation (PUMA) for the treatment of children with attention-deficit hyperactivity disorder.

The committee adopted positive opinions for six biosimilar medicines:

• Avtozma (tocilizumab) for rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced severe or life-threatening cytokine release syndrome and COVID-19.
• Eydenzelt (aflibercept) for neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation.
• Osenvelt (denosumab) for the prevention of bone complications in adults with advanced cancer involving the bone, and for the treatment of adults and skeletally mature adolescents with giant cell bone tumour.
• Stoboclo (denosumab) for osteoporosis in women who have been through menopause, bone loss linked to hormone ablation in men at increased risk of fractures, and bone loss associated with long-term treatment with systemic glucocorticoid.
• Yesintek (ustekinumab) for adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease.
• Zefylti (filgrastim) for neutropenia and the mobilisation of peripheral blood progenitor cells.

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.

Finally, 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.