- Belgian pharmaceutical firm Galapagos ( NASDAQ: GLPG ) on Monday said the European Union's human medicines committee had recommended amending the label of its inhibitor Jyseleca to remove a warning regarding its effect on testicular function.
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on GLPG's type 2 variation application, GLPG said in a statement .
- Jyseleca is indicated for the treatment of patients with inflammatory bowel disease and rheumatic conditions.
- The variation application was supported by interim data from two ongoing studies called MANTA and MANTA-RAy, GLPG said.
- The CHMP concluded that the interim data did not suggest that Jyseleca had an effect on the testicular function of patients.
- Following the CHMP's opinion, Jyseleca's label will be amended to remove the language in the section of special warnings and precautions about the potential effect of the drug on sperm production and male fertility.
- U.S.-listed shares of GLPG earlier closed +0.5% at $42.85.
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EMA panel approves amending label for Galapagos' Jyseleca on testicular function effects