ARTICLE | Clinical News

Cladribine tablets regulatory update

September 27, 2010 7:00 AM UTC

CHMP issued a negative opinion recommending against approval of an MAA for Merck's cladribine tablets to treat relapsing-remitting multiple sclerosis (RRMS). The committee expressed concern about an increased number of cancer cases in patients treated with cladribine, which the committee said may indicate an increased risk of cancer over time and with increasing doses. CHMP also noted that the benefits and the most appropriate dosage of cladribine were not fully established. CHMP is part of the European Medicines Agency (EMA). ...