Cladribine tablets regulatory update

Merck's Merck Serono S.A. division said it notified European Medicines Agency (EMA) of its intention to request a re-examination of a recommendation last month against approval of cladribine tablets for relapsing-remitting multiple sclerosis (RRMS) (see BioCentury, Sept. 27). In its opinion, EMA's CHMP expressed concern about an increased number of cancer cases in patients treated with the product, which the committee said may indicate an increased risk of cancer over time and with increasing doses. The company has 60 days from receipt of CHMP's opinion to provide the agency with detailed grounds for re-examination. ...