Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2021
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 medicines: Abiraterone 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.
Agenda and minutes
Key figures from the April 2021?CHMP?meeting are represented in the graphic below.
*This product was designated as an?orphan medicine?during its development.?Orphan designations?are reviewed by EMA's?Committee for Orphan Medicinal Products?(COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of?market exclusivity.
|Name of medicine||Enspryng|
|Marketing-authorisation applicant||Roche Registration GmbH|
|Therapeutic indication||Treatment of neuromyelitis optica spectrum disorders (NMOSD)|
Press release:New treatment for rare autoimmune disease of nerve cells
Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 19-22 April 2021 (PDF/153.83 KB) (new)Adopted
First published: 29/04/2021
Scientific advice and protocol assistance adopted during the CHMP meeting 19-22 April 2021 (PDF/247.87 KB) (new)Adopted
First published: 23/04/2021