Psoriatic arthritis, ok Ema experts at AbbVie monoclonal

Green light from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency EMA to the monoclonal antibody risankizumab (Skyrizi *, 150 mg), administered by subcutaneous injection at week 0, week 4 and every 12 weeks thereafter, alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adults who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs. This was announced by the American AbbVie, recalling that the positive opinion of the CHMP represents a scientific recommendation for the granting of the marketing authorization (Aic) by the European Commission. The positive opinion of Ema experts – explains the company in a note – is supported by data from 2 phase 3 clinical trials, KEEPsAKE-1 and KEEPsAKE-2, which evaluated risankizumab in adults with active psoriatic arthritis, including patients who had had an inadequate response or intolerance to biological therapy and / or disease-modifying non-biological antirheumatic drugs (Dmards). The efficacy and safety profile of risankizumab up to 52 weeks was consistent with the profile observed at 24 weeks. “We are very satisfied that the CHMP has recognized the potential of risankizumab in controlling the skin and joint manifestations of psoriatic arthritis, improving the quality of life – says Annalisa Iezzi, medical director of AbbVie Italy – The results of clinical studies confirm that risankizumab can ensure significant improvement over the long term. This is an important milestone in our ongoing search for innovative therapies that address the unmet needs of patients with immune-mediated inflammatory diseases. “” Psoriatic arthritis is a chronic inflammatory disease that it affects the joints – says Luca Bianchi, UOSD director of Dermatology, Tor Vergata Polyclinic in Rome – in which skin signs and symptoms overlap with those typical of arthritis, including pain and the state of joint inflammation. patients continue to show these symptoms. The results of the studies provide important insights on how both naïve patients and those already treated with biological therapies can benefit from treatment with risankizumab. “If the CHMP recommendation is accepted by the European Commission – AbbVie points out – that against psoriatic arthritis the second indication for risankizumab in the European Union, following approval in 2019 for the treatment of plaque psoriasis in adults. The marketing authorization will be valid in all EU Member States, as well as Iceland, Liechtenstein , Norway and Northern Ireland. Risankizumab is a selective inhibitor of interleukin-23 (IL-23), a cytokine involved in inflammatory processes, which is thought to be related to several chronic immune-mediated diseases, including psoriasis. AbbVie and the German company Boehringer Ingelheim. The US company will be responsible for the development and marketing of the product. global fleece.