Merck KGaA is to request a re-examination of the negative opinion issued last month by European regulators regarding its oral drug cladribine for the treatment of relapsing-remitting multiple sclerosis (MS), the company reported Monday.
In September, the European Medicines Agency's Committee for Medicinal Products for Human Use indicated that based on data included in the company's regulatory filing, the benefits of cladribine do not outweigh its risks. At the time, Elmar Schnee, head of Merck's drug unit, noted the agency raised concerns about cases of cancer seen in clinical trials of the drug, as well as cases of lymphopenia.
A decision on the drug, which has been approved in Russia and Australia, in the US is expected in the fourth quarter of the year, after the company's initial regulatory filing was rejected by the FDA as incomplete.
Last month, Novartis' Gilenya (fingolimod) became the first oral drug to be approved in the US as a first-line treatment for relapsing forms of MS, while a decision on the product in Europe is anticipated during the next six months.
Reference Articles
Merck KGaA to appeal European panel view on cladribine - (FOX Business)
Merck KGaA to ask EU agency to reconsider MS pill - (Forexpros)
Merck KGaA notified EMA of its intention to appeal CHMP opinion on cladribine tablets in MS - (Merck KGaA)
**Published by "First Word"