Merck KGaA: FDA Grants Priority Review to Cladribine Tablets for the Treatment of Relapsing Forms of Multiple Sclerosis
Merck KGaA / Regulatory Admission
28.07.2010 08:00
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted by
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The issuer is solely responsible for the content of this announcement.
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Darmstadt, Germany, July 28, 2010 - Merck KGaA announced today that the
U.S. Food and Drug Administration (FDA) has accepted for filing the New
Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing
forms of multiple sclerosis (MS).
The application also has been granted a Priority Review designation by the
FDA, which means the review period for the NDA is reduced. The goal for
completing a Priority Review is six months instead of the standard ten
months. Priority Review is applied to drugs that have the potential to
provide significant advances in treatment. A decision by the FDA is
expected in Q4 2010.
Phyllis Carter
Phone +49 6151 72-7144
28.07.2010 Ad hoc announcement, Financial News and Press Release distributed by DGAP.
Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: Merck KGaA
Frankfurter Str. 250
64293 Darmstadt
Deutschland
Phone: +49 (0)6151 72 - 3321
Fax: +49 (0)6151 72 - 913321
E-mail: investor.relations@merck.de
Internet: www.merck.de
ISIN: DE0006599905
WKN: 659990
Indices: DAX
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Hannover, Stuttgart, Hamburg;
Terminbörse EUREX; Foreign Exchange(s) London, SIX
End of News DGAP News-Service
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