At its December 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for CSL’s Andembry® (garadacimab) for prevention of recurrent attacks of hereditary angioedema (HAE). Galderma’s Nemluvio® (nemolizumab), for treatment of atopic dermatitis and prurigo nodularis, and AstraZeneca’s Kavigale® (sipavibart), for prevention of COVID-19 in immunocompromised people aged 12 years and older, also received positive opinions.
Indication expansions were recommended for seven medicines including Amgen’s Blincyto® (blinatumomab) as monotherapy (as part of consolidation therapy) for newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor ALL; GSK’s Jemperli® (dostarlimab) for first line treatment (with chemotherapy) of all primary advanced or recurrent endometrial cancer who are candidates for systemic therapy; and Eli Lilly’s Omvoh® (mirikizumab) for moderately to severely active Crohn’s disease.
Six biosimilars received positive opinions at CHMP’s December meeting as reported here.