EMA/PRAC starts safety review of JAK inhibitors for inflammatory disorders

Already marketed and pipeline candidate Janus kinase (JAK) inhibitors have recently suffered setbacks in the USA, since the Food and Drug Administration found safety issues with the class of drugs and ordered Back Box label warnings.

But now they are likely to face more problems, as the European Medicines Agency says that its Pharmacovigilance Risk Assessment Committee (PRAC) has launched an investigation.

The PRAC has started a review of the safety of JAK inhibitors used to treat several chronic inflammatory disorders (rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, ulcerative colitis and atopic dermatitis)