Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2023

Eight new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2023 meeting.

The CHMP adopted a positive opinion for Omjjara* (momelotinib), for the treatment of myelofibrosis, a rare blood cancer that affects the bone marrow.

Rystiggo* (rozanolixizumab), intended for the treatment of generalised myasthenia gravis, received a positive opinion. Myasthenia gravis is a chronic autoimmune neuromuscular condition that causes muscle weakness in different parts of the body.

A positive opinion was adopted for Spexotras* (trametinib) for the treatment of paediatric patients aged one year and older with glioma, a type of brain tumour that begins in glial cells (the cells that surround and support nerve cells)…