Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Type II variation application for Jyseleca® (filgotinib), a once-daily, oral, JAK1 preferential inhibitor, to amend the European label regarding testicular function after treatment of patients with inflammatory bowel disease (IBD) and rheumatic conditions (RC).
Type II variation (1) regulatory application to amend the European label of Jyseleca® (filgotinib) based on data from MANTA and MANTA-RAy studies in patients with inflammatory bowel disease (IBD) and rheumatic conditions (RC) respectively
Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos said, “This positive CHMP opinion marks a key milestone for Jyseleca and provides important information for patients and physicians, given it is the only anti-inflammatory drug that has been evaluated in a robust, large-scale, placebo-controlled trial program for the potential effect on male reproduction. We will now work to update all relevant label information and materials with the aim to increase access to Jyseleca so that European patients who may benefit from the treatment are able to receive it.”
The Type II variation application was submitted to the EMA in June 2022, 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 RC.
Following assessment of the interim data by the CHMP, it was concluded in the opinion that the data did not reveal a difference between treatment groups in the proportion of patients who had a 50% or more decrease from baseline in semen parameters at week 13 (pooled primary endpoint: filgotinib 6.7%, placebo 8.3%) and at week 26. Further, CHMP concluded that the data did not show any relevant changes in sex hormone levels or change from baseline in semen parameters across treatment groups. Overall, CHMP concluded that these clinical data were not suggestive of filgotinib-related effects on testicular function.
Following the positive CHMP opinion, the language in the section of the Special Warnings and Precautions about the potential effect of filgotinib on sperm production and male fertility will be removed from the Summary of Product Characteristics (SmPC), and the MANTA/MANTA-RAy studies will be removed from the Risk Management Plan (RMP).
The design of the MANTA and MANTA-RAy studies was published in Advances in Therapy in June 2022 (2), and Galapagos is planning to publish the results in a peer-reviewed medical journal next year.
(1) A Type II variation is defined by EMA as a major change to an existing marketing authorization that may have a significant impact on the quality, safety or efficacy of a medicine, but does not involve a change to the active substance, its strength or the route of administration