The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended eight new medicines for approval in its April meeting.
Leading those recommendations is Roche’s Enspryng (satralizumab), which received a positive opinion for the treatment of the rare autoimmune disease neuromyelitis optica spectrum disorders (NMOSD).
The antibody has been recommended for the treatment of NMOSD in adults and adolescents from 12 years of age who are positive for anti-aquaporin-4 antibodies (AQP4-IgG).
NMOSD, a rare and life-threatening condition, affects the optic nerves and spinal cords and can cause a reduction or loss of vision, loss of sensation, loss of bowel and bladder control as well as weakness and paralysis of the arms and legs.
“Today’s positive CHMP opinion is an important step toward bringing Enspryng to people in the EU living with NMOSD who have limited treatment options,” said Levi Garraway, chief medical officer and head of global product development.
“Enspryng has been shown to reduce the risk of relapse significantly, while also offering a favourable safety profile,” he added.
In addition, Regeneron’s Evkeeza (evinacumab) scored a positive opinion for the treatment of homozygous familial hypercholesterolemia (HoFH) in adult and adolescent patients aged 12 years and older.
The CHMP also recommended granting a marketing authorisation for Leo Pharma’s monoclonal antibody Adtralza (tralokinumab) for the treatment of adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
AstraZeneca’s rare disease med Koselugo (selumetinib) bagged a CHMP recommendation for the treatment of the genetic condition neurofibromatosis type 1 (NF1) plexiform neurofibromas (PN) in paediatric patients.
Meanwhile, the CHMP adopted a positive opinion for Celgene’s Onureg (azacitidine) as a maintenance treatment of patients with acute myeloid leukaemia.
The CHMP also recommended granting marketing authorisation for the generic medicines Abiraterone Krka (abiraterone acetate) and Celsunax (ioflupane (123I)) for the treatment of adult men with metastatic prostate cancer and to detect the loss of functional dopaminergic neuron terminals in the striatum, respectively.
Finally, the CHMP adopted a positive opinion for Nova Laboratories’ hybrid medicine Jayempi (azathioprine), which is intended for prophylaxis against transplant rejection and as immunosuppressive antimetabolite, either alone or in combination with other agents.
