November 2023 batch of EMA/CHMP recommendations
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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