EMA gives green light for 8 new medicines

The European Medicine Agency’s key decision-making committee on human medicines (CHMP), has recommended eight medicines for approval at its June meeting. 

The Committee recommended granting a conditional marketing authorisation for Abecma (idecabtagene vicleucel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three previous therapies, and whose cancer has worsened since receiving the last treatment.

The Committee adopted a positive opinion for Voxzogo (vosoritide) for the treatment of achondroplasia in patients two years of age and above whose epiphyses are not closed. Achondroplasia is a condition that impairs bone growth and causes dwarfism.

Conditional marketing authorisation was recommended for Minjuvi (tafasitamab) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem-cell transplant.

The Committee adopted a positive opinion, recommending the granting of a marketing authorisation for Bimzelx (bimekizumab) for the treatment of moderate to severe plaque psoriasis.

Byooviz (ranibizumab) was given the green light for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularisation.

Evrenzo (roxadustat) was granted a positive opinion for the treatment of anaemia symptoms in patients with chronic kidney disease.

The CHMP recommended granting marketing authorisations for two generic medicines: Abiraterone Mylan (abiraterone acetate) for the treatment of metastatic prostate cancer and Fingolimod Mylan (fingolimod) for the treatment of relapsing-remitting multiple sclerosis with high disease activity.

A total of 50 new medicines were approved in the EU in the first six months of 2021, with a further 46 extensions of therapeutic indication.