BOLOGNA (ITALPRESS) – Alfasigma S.p.A, a global pharmaceutical company focused on rare diseases and specialty care today announced that the European Commission has approved a further indication for Jyseleca (filgotinib) 200 mg and 100 mg tablets coated with films, a preferential JAK1 inhibitor in oral daily mono administration, for the treatment of patients with axial spondylarthritis The application for the extension of the indications was also submitted to the British MHRA Agency and is currently under review. “The approval by the European Commission is based on data that demonstrates a risk-benefit profile for filgotinib – explains Alfasigma in a note –. The clinical study of Phase 3 OLINGUITO (published this year on Annals of the Rheumatic Diseases) has demonstrated the efficacy and safety of filgotinib and evidenced an improvement of the signs and symptoms of axSpA since week 1, maintained then for the entire duration of the treatment (52 weeks)”. AxSpA is a chronic pathology and is particularly complex in long-term management; although several advanced therapies are available, half of patients currently do not respond adequately to treatment. The approval of a new anti-reumatic drug that affects the disease is an important step for those who live daily with axial spondyloarthritis: we are collaborating with the European authorities to make the drug available properly after approval.” Although there are numerous therapeutic options that provide for the use of anti-inflammatory drugs, only a percentage between 40% and 50% of patients with axSpA manifest an adequate response to treatment. Even less is the percentage of patients who reach remission or a state of inactivity of the disease (about 10-20%) within 16-24 weeks from the beginning of treatment. Chronic back pain is the most common manifestation of axSpA. 70% of people living with the disease report a high intensity pain, which has a strong impact on their quality of life and which persists despite the treatment: an effective control of pain therefore represents an absolute priority in the management of the disease. The clinical study of Phase 3 OLINGUITO has shown that about 40-44% of patients to whom phylgotinib has been administered has reached the inactive phase of the disease (ID) or a low activity of the disease (LDA) according to the ASDAS score at week 16, with a percentage of patients increased up to 58-61% per week 52; such results have been consistent independently from previous treatments with anti-reumatic drugs “The extension of the indication of filgotinib by the European Commission provides doctors andpatients an additional therapeutic option, which brings proven improvements on important manifestations of axial spondyloarthritis. Expanding the therapeutic panorama with additional options, including oral administration, can help doctors provide more patient support, offering a more personalized approach.” “In Italian clinical practice, axial spondyloarthritis confronts patients with different needs, due to disease characteristics, health conditions and previous therapeutic experiences as well as different expectations from therapy,” says Professor Carlo Selmi (pictured), Responsible of the UO of Reumatology and Clinical Immunology at IRCS Humanitas and professor at Humanitas University. “Enhancing the available options means you can better adapt the care to these differences, considering effectiveness, safety and individual preferences. An oral drug can meet the needs of those who prefer an alternative to injective administrations. The reduction of pain observed in the first few weeks in the OLINGUITO study is an element of particular interest: for the patient it means being able to feel an early benefit on a symptom that affects sleep, movement and daily activities.”.
– Alfasigma press office photos –
(ITALPRESS).
