BioCentury
ARTICLE | Company News

EMA again reviewing Merck KGaA's MS therapy cladribine

July 18, 2016 7:00 AM UTC

Merck KGaA (Xetra:MRK) said EMA accepted a resubmitted MAA for cladribine tablets to treat relapsing-remitting multiple sclerosis. Merck withdrew an MAA for the candidate in 2011 following a negative opinion from EMA's CHMP.

The company said its resubmission includes data from the Phase III CLARITY, CLARITY EXTENSION and ORACLE MS studies, as well as the Phase II ONWARD study. It completed the last three studies after withdrawing the first MAA. ...