CHMP negative for approval of Raylumis as a proposed treatment for pain associated with osteoarthritis.
Although Raylumis showed better pain relief and improved physical functioning in patients with osteoarthritis affecting the hip or knee compared with placebo, the difference was small. In addition, there was no improvement in pain relief and physical functioning when compared with NSAIDs. In terms of safety, patients on Raylumis were at an increased risk of side effects, such as rapid progressive osteoarthritis and joint replacement, compared with patients receiving placebo or NSAIDs
Therefore, the Agency’s opinion was that the benefits of Raylumis in patients with an insufficient response to NSAIDs or opioids were unclear and did not outweigh its risks and recommended refusing marketing authorisation.
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