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26 January 2011

EU regulator re-confirms negative decision for Merck KGaA's cladribine

Following an appeal by Merck KGaA, regulators in Europe reconfirmed their initial negative opinion issued last year regarding a marketing submission for cladribine as a treatment for relapsing-remitting multiple sclerosis, the company announced.
According to Merck, the majority of members of the European Medicines Agency's Committee for Medicinal Products for Human Use indicated that the benefits of the oral drug do not outweigh its risks, although some voted in favour of a conditional approval. "The expectations for this appeal being successful were never high, and consensus has by now mostly removed revenues for cladribine from Merck estimates," analysts at WestLB noted.
Company spokesman Gangolf Schrimpf suggested that the drugmaker won't be able to appeal the decision without new clinical data. The drug is being investigated in a number of clinical trials, with top-line results from the CLARITY EXTENSION and ORACLE MS studies expected by the end of 2011, and top-line data from the ONWARD trial anticipated in the first half of 2012. "If the data is good, we still have a chance to apply," Schrimpf said.
"This is really negative news for Merck," commented Frank Schneider of brokerage firm Alpha. Cladribine, which has been approved in Russia and Australia, is also under regulatory review in the US, where the FDA recently delayed a decision on the drug until February. Some analysts saw that as a positive sign for approval in the US, although WestLB analysts warned that "expectations for a positive decision by the FDA are not high either."
Novartis' MS drug Gilenya (fingolimod) was approved in the US in September last year, making it the first oral compound for the disease to be cleared in the country. The drug also garnered a positive opinionl by the CHMP.

Reference Articles
Merck KGaA says EU drug agency won't back MS pill cladribine after review - (Bloomberg)
EU drug watchdog deals another blow to Merck KGaA - (FinanzNachrichten)
Merck muss Hoffnung auf wichtigstes Medikament begraben - (Handelsblatt)
Merck KGaA announces outcome of its request for reexamination of CHMP opinion for cladribine tablets in MS - (Merck KGaA)
EU rejects Merck's multiple-sclerosis pill (free preview) - (The Wall Street Journal)

**Published in "First Word"

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