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CHMP recommends eight new medicines for EU approval

BMS’ CAR T therapy Abecma and BioMarin’s dwarfism drug Voxzogo among positive recommendations

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisations for a total of eight new drugs in its June decisions. 

The positive opinions include Bristol Myers Squibb’s CAR T therapy Abecma (idecabtagene vicleucel) as a potential new treatment for highly refractory multiple myeloma.

The CHMP has recommended a conditional marketing authorisation for Abecma as a treatment for adult patients with relapsed and refractory multiple myeloma who have received at least three previous therapies.

Next up is BioMarin’s Voxzogo (vosoritide), which has been recommended for the treatment of achondroplasia in patients aged two years and above whose epiphyses (growth plates) have not closed.

Achondroplasia is a condition that impairs bone growth and causes dwarfism. In a phase 3 study, participants treated with BioMarin’s drug gained annual growth of 1.57cm over placebo, with Voxzogo-treated patients gaining 2.2cm in height compared to what their natural history would suggest.

The CHMP also adopted a positive opinion for MorphoSys and Incyte’s Monjuvi (tafasitamab) for the treatment of relapsed or refractory diffuse B-cell lymphoma (DLBCL) for patients who are not eligible for stem cell transplantation.

In July 2020, the US Food and Drug Administration (FDA) approved Monjuvi in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL.

“Patients with relapsed or refractory DLBCL have limited treatment options and often face a poor prognosis. There is an urgent need for effective therapies and if approved, this combination could provide patients in Europe with an important new therapeutic option,” said Malte Peters, chief research & development officer, MorphoSys.

The CHMP has also recommended approval of UCB’s Bimzelx (bimekizumab) for the treatment of moderate-to-severe plaque psoriasis, while Genetech’s Byoovis (ranibizumab) also received a positive opinion from the CHMP.

Byoovis is designed for the treatment of wet age-related macular degeneration (AMD), 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.

Finally, the CHMP has adopted positive opinions for Astellas and FibroGen’s Evrenzo (Roxadustat) for the treatment of anaemia symptoms in chronic kidney disease patients.

Two generic medicines also received positive opinions from the CHMP: Abiraterone Mylan (abiraterone acetate), a generic of Janssen’s Zytiga, for the treatment of metastatic prostate cancer and Fingolimod Mylan (fingolimod), a generic of Novartis’ Gilenya, for relapsing-remitting multiple sclerosis with high disease activity.

Article by
Lucy Parsons

28th June 2021

From: Regulatory



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