European label update for Jyseleca based on testicular function safety data from MANTA-studies

The European Medicines Agency (EMA) has approved a label update for Jyseleca. The update is based on an assessment concluding that the clinical data were not suggestive of filgotinib-related effects on testicular function.

MANTA is a long-term placebo-controlled Phase 2 safety study in men with moderately to severely active UC or CD, assessing testicular function and semen parameters while being treated with filgotinib. MANTA-Ray is a similar study in men with various rheumatic conditions.

The rationale for the studies was to elucidate the clinical relevance of the testicular toxicity findings observed in preclinical studies in animals. The studies assess short-term and long-term clinical safety data on the effects of filgotinib on testicular function and semen parameters, and are ongoing.

Change in language for special warnings and precautions

The type II variation application to EMA was supported by interim data on the primary, secondary and exploratory endpoints at week 13 and 26 for subjects who met a prespecified sperm decrease at these timepoints (up to week 52) from the ongoing MANTA and MANTA-Ray studies, investigating the potential effect of filgotinib use on semen parameters and sex hormones in adult patients with IBD and various rheumatic conditions.

Overall the Committee for Medicinal Products for Human Use (CHMP), concluded that these clinical data were not suggestive of filgotinib-related effects on testicular function. Therefore, the label warning and precaution paragraph on the potential risk of impaired spermatogenesis will be removed, the high level results from the MANTA/MANTA-Ray studies will be included into the fertility section of the label, and the potential risk removed from the EU Risk Management Plan.