Eight new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2021 meeting.

The Committee gave a positive opinion for Enspryng* (satralizumab) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive. See more details in the news announcement in the grid below.

Evkeeza (evinacumab) was granted a positive opinion by the Committee for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Evkeeza was reviewed under EMA’s accelerated assessment programme.

The Committee recommended granting a marketing authorisation for Adtralza (tralokinumab) for the treatment of adults with moderate to severe atopic dermatitis who are candidates for systemic therapy.

Koselugo* (selumetinib) was granted a positive opinion for the treatment of paediatric patients with neurofibromatosis type 1 (NF1) plexiform neurofibromas (PN).

The Committee adopted a positive opinion for Onureg (azacitidine) for the maintenance treatment of patients with acute myeloid leukemia.

The CHMP recommended granting marketing authorisations for two generic medicinesAbiraterone Krka (abiraterone acetate) for the treatment of adult men with metastatic prostate cancer and Celsunax (ioflupane (123I)) intended for detecting loss of functional dopaminergic neuron terminals in the striatum.

The Committee recommended granting a marketing authorisation for the hybrid medicine Jayempi (azathioprine) intended for prophylaxis against transplant rejection and as immunosuppressive antimetabolite either alone or in combination with other agents to influence the immune response in a variety of diseases. Hybrid applications 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.

Nine recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Aubagio, BiResp Spiromax, DuoResp Spiromax, Maviret, Nulojix, Opdivo, Tagrisso, Venclyxto and Yervoy.

Posted on the EMA website on 23 April 2021