Janus kinase inhibitors used for chronic inflammatory conditions are only safe for certain patients, advises the EMA’s safety committee.
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The latest meeting saw EMA’s human medicines committee (CHMP) recommend the approval of nine new medicines, refuse two biosimilar medications and recommend extensions of therapeutic indication for six medicines.
NICE has recommended Pfizer’s Xeljanz® (tofacitinib) as an option to treat polyarticular juvenile arthritis and juvenile psoriatic arthritis.
Xeljanz® (tofacitinib) received marketing authorisation in Europe for the treatment of juvenile idiopathic arthritis (JIA) and psoriatic arthritis (PsA).
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
The EMA CHMP has revealed its suggestion to grant marketing authorisation to seven medicines after its most recent meeting.