Sort II variation1 regulatory utility to amend the European label of Jyseleca® (filgotinib) based mostly on knowledge from MANTA and MANTA-RAy research in sufferers with inflammatory bowel illness (IBD) and rheumatic situations (RC) respectively
Mechelen, Belgium; 3 October 2022, 22.01 CET, regulated data; Galapagos NV (Euronext & NASDAQ: GLPG) immediately announced that the Committee for Medicinal Merchandise for Human Use (CHMP), the scientific committee of the European Medicines Company (EMA), has adopted a optimistic opinion on the firm’s Sort II variation utility for Jyseleca® (filgotinib), a once-daily, oral, JAK1 preferential inhibitor, to amend the European label relating to testicular operate after remedy of sufferers with inflammatory bowel illness (IBD) and rheumatic situations (RC).
Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos mentioned, “This optimistic CHMP opinion marks a key milestone for Jyseleca and gives essential data for sufferers and physicians, given it’s the solely anti-inflammatory drug that has been evaluated in a sturdy, large-scale, placebo-controlled trial program for the potential impact on male replica. We’ll now work to replace all related label data and supplies with the intention to extend entry to Jyseleca in order that European sufferers who might profit from the remedy are capable of obtain it.”
The Sort II variation utility was submitted to the EMA in June 2022, supported by interim knowledge on the first, secondary and exploratory endpoints at Week 13 and 26 for topics who met a prespecified sperm lower at these timepoints (as much as Week 52) from the continued MANTA and MANTA-RAy research, investigating the potential impact of filgotinib use on semen parameters and intercourse hormones in grownup sufferers with IBD and varied RC.
Following evaluation of the interim knowledge by the CHMP, it was concluded within the opinion that the information didn’t reveal a distinction between remedy teams within the proportion of sufferers who had a 50% or extra lower from baseline in semen parameters at week 13 (pooled major endpoint: filgotinib 6.7%, placebo 8.3%) and at week 26. Additional, CHMP concluded that the information didn’t present any related modifications in intercourse hormone ranges or change from baseline in semen parameters throughout remedy teams. General, CHMP concluded that these medical knowledge weren’t suggestive of filgotinib-related results on testicular operate.
Following the optimistic CHMP opinion, the language within the part of the Particular Warnings and Precautions concerning the potential impact of filgotinib on sperm manufacturing and male fertility shall be faraway from the Abstract of Product Traits (SmPC), and the MANTA/MANTA-RAy research shall be faraway from the Danger Administration Plan (RMP).
The design of the MANTA and MANTA-RAy research was printed in Advances in Remedy in June 20222, and Galapagos is planning to publish the ends in a peer-reviewed medical journal subsequent 12 months.
Filgotinib is marketed as Jyseleca (200mg and 100mg tablets) within the European Union (incl. Norway), Nice Britain, and Japan for the remedy of adults with reasonably to severely energetic rheumatoid arthritis (RA) who’ve responded inadequately or are illiberal to a number of illness modifying anti-rheumatic medicine (DMARDs). Filgotinib can also be marketed as Jyseleca (200mg tablets) within the European Union (incl. Norway), Nice Britain, and Japan for the remedy of grownup sufferers with reasonably to severely energetic ulcerative colitis (UC) who’ve had an insufficient response with, misplaced response to, or have been illiberal to both typical remedy or a biologic agent. A worldwide Part 3 program with filgotinib is ongoing in Crohn’s Illness. Extra details about medical trials might be accessed at https://www.clinicaltrials.gov.
The European Abstract of Product Traits for filgotinib, which incorporates contraindications and particular warnings and precautions, is obtainable at www.ema.europa.eu. The Nice Britain Abstract of Product Traits for filgotinib might be discovered at www.medicines.org.uk/emc and the Northern Eire Abstract of Product Traits for filgotinib might be discovered at www.emcmedicines.com/en-GB/northernireland, respectively. The interview kind from the Japanese Ministry of Well being, Labour and Welfare is obtainable at www.info.pmda.go.jp.
Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its associated firms. Apart from filgotinib’s approval as Jyseleca for the remedy of reasonably to severely RA and UC by the related regulatory authorities in the European Union, Nice Britain, and Japan, our drug candidates are investigational; their efficacy and security haven’t been absolutely evaluated by any regulatory authority.
In regards to the MANTA and MANTA-RAy studies
MANTA is a long-term, placebo-controlled Part 2 security examine in males with reasonably to severely energetic ulcerative colitis (UC) or Crohn’s illness (CD) to evaluate semen parameters whereas taking filgotinib. MANTA-RAy is the same examine in males with energetic rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondylarthritis. These research have been designed with the enter of the related well being authority and will not be powered for statistical comparability between teams. For the first endpoint evaluation, databases of each research have been pooled, and the outcomes have been introduced in March 2021.
Galapagos is a totally built-in biotechnology firm targeted on discovering, creating, and commercializing revolutionary medicines. We’re dedicated to enhancing sufferers’ lives worldwide by focusing on ailments with excessive unmet wants. Our R&D capabilities cowl a number of drug modalities, together with small molecules and cell therapies. Our portfolio contains discovery by means of to Part 4 applications in irritation, oncology, fibrosis, and different indications. Our first medication for rheumatoid arthritis and ulcerative colitis is obtainable within the European Union, Norway, Nice Britain, and Japan. For added data, please go to www.glpg.com or observe us on LinkedIn or Twitter.
Sofie Van Gijsel
Head of Investor Relations
+1 781 296 1143
Director Investor Relations
+32 495 58 46 63
Head of Company Communication
+32 479 490 603
This press launch consists of forward-looking statements, all of which contain sure dangers and uncertainties. These statements are sometimes, however will not be all the time, made by means of the usage of phrases or phrases corresponding to “might,” “guarantee,” “potential,” “will,” and “plan,” in addition to related expressions. Ahead-looking statements contained on this launch embody, however will not be restricted to, statements relating to Galapagos’ plans and technique with respect to Jyseleca and the MANTA and MANTA-Ray research. Any forward-looking statements on this launch are based mostly on Galapagos administration’s present expectations and beliefs and will not be ensures of future efficiency. Ahead-looking statements contain recognized and unknown dangers, uncertainties and different components which could trigger Galapagos’ precise outcomes, efficiency or achievements to be materially totally different from any historic or future outcomes, efficiency or achievements expressed or implied by such forward-looking statements. These dangers, uncertainties and different components embody, with out limitation, the danger that ongoing and future medical research with filgotinib will not be accomplished within the at the moment envisaged timelines or in any respect, the inherent dangers related to medical trial and product improvement actions, together with the filgotinib medical program and the FINCH 4 LTE examine, the inherent dangers and uncertainties related to aggressive developments, medical trial and product improvement actions and regulatory approval necessities (together with that knowledge from the continued and deliberate medical analysis applications, together with however not restricted to the information from the continued MANTA and MANTA-RAy trials, might not help registration or additional improvement of filgotinib attributable to security, efficacy or different causes), the dangers associated to continued regulatory evaluation of filgotinib following approval by related regulatory authorities, together with EMA’s deliberate security evaluation of JAK inhibitors used to deal with sure inflammatory issues, the dangers that regulatory authorities might require extra post-approval trials of filgotinib or every other product candidates which can be authorized sooner or later, Galapagos’ reliance on collaborations with third events (together with our collaboration accomplice for filgotinib, Gilead) and that Galapagos’ estimations relating to its filgotinib improvement program and relating to the industrial potential of filgotinib could also be incorrect, the danger that Galapagos will be unable to proceed to execute on its at the moment contemplated marketing strategy and/or might want to revise its marketing strategy, and dangers associated to the continued COVID-19 pandemic, in addition to these dangers and uncertainties recognized in our most up-to-date Annual Report on Type 20-F filed with the U.S. Securities and Change Fee (SEC), as supplemented and/or modified by every other filings and reviews that we have now made or will make with the SEC sooner or later. Given these dangers and uncertainties, the reader is suggested to not place any undue reliance on such forward-looking statements. As well as, even when Galapagos’ outcomes, efficiency or achievements are in keeping with such forward-looking statements, they will not be predictive of outcomes, efficiency or achievements in future durations. These forward-looking statements communicate solely as of the date of publication of this launch. Galapagos expressly disclaims any obligation to replace any such forward-looking statements on this launch except required by legislation or regulation.
1 A Sort II variation is outlined by EMA as a serious change to an present advertising and marketing authorization that will have a major affect on the standard, security or efficacy of a drugs, however doesn’t contain a change to the energetic substance, its power or the route of administration
2 MANTA and MANTA-RAy: Rationale and Design of Trials Evaluating Effects of Filgotinib on Semen Parameters in Patients with Inflammatory Diseases – PubMed (nih.gov)