November 2023 batch of EMA/CHMP recommendations

11 November 2023

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended four novel medicines and two biosimilars for approval at its November 2023 meeting.

The CHMP adopted a positive opinion for Omjjara (momelotinib), from UK pharma major GSK (LSE: GSK) for the treatment of myelofibrosis, a rare blood cancer that affects the bone marrow. Under the trade name Ojjaara, in August the drug gained US regulatory approval for the treatment of intermediate or high-risk myelofibrosis.

Rystiggo (rozanolixizumab), from Belgium’s UCB (Euronext: UCB), which is intended for the treatment of generalized myasthenia gravis, received a positive opinion. Myasthenia gravis is a chronic autoimmune neuromuscular condition that causes muscle weakness in different parts of the body.

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