美國FDA 駁回 Merk藥廠的MS 藥物(cladribine)的申請, 但Merk不會放棄,繼續協調和溝通.
German pharmaceutical company Merck KGaA on Monday said its application for U.S. approval of cladribine tablets for multiple sclerosis treatment has been rejected by the U.S. Food and Drug Administration.
The FDA issued a "refuse to file letter" to the company, which it does when it decides a new drug application isn't sufficiently complete.
"It is the worst of all possibilities," Sal. Oppenheim analyst Peter Duellmann said. "Until now, the question was whether the drug will get a priority review or not. Now the FDA won't even look at it."
Multiple sclerosis is a chronic, inflammatory condition of the central nervous system that can be disabling in its advanced stages. Cladribine, according to Merck KGaA, is a small molecule that may interfere with certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS.
At the end of September, Merck KGaA applied for U.S. approval of cladribine tablets as a potential short-course therapy for multiple sclerosis.
The move gave it a lead over Swiss competitor Novartis AG, which plans to file for European Union and U.S approval of FTY720, also known by its generic name fingolimod, at the end of this year.
"The company will work closely with the FDA to fully understand the FDA's concerns and define a path forward for a successful resubmission of this application at the earliest point in time," Merck KGaA said in a statement.
Merck had applied to the European Medicines Agency for EU approval of the drug in July, in a bid to bring to market the first oral treatment against the nervous-system disease.
Write to Natascha Divac at firstname.lastname@example.org