US FDA refuses Merck's cladribine NDA

Published: 30-Nov-2009

The US Food and Drug Administration (FDA) has rejected Merck KGaA\'s New Drug Application (NDA) for multiple sclerosis tablet cladribine.


The US Food and Drug Administration (FDA) has rejected Merck KGaA's New Drug Application (NDA) for multiple sclerosis tablet cladribine.

The FDA has issued a "refuse to file" letter in response to Merck's application for cladribine, which would be the first oral treatment against relapsing forms of multiple sclerosis.

"The company will work closely with the FDA to understand the FDA's concerns and define a path forward for a successful resubmission of this application at the earliest point in time," said Elmar Schnee, executive board member of Merck and head of the Merck Serono division.

Swiss rival Novartis is planning to seek US and European approval for an experimental multiple sclerosis treatment known as FTY720, which disrupts the movement of immune cells into the bloodstream at the end of this year.

This is the second time that regulators have refused to approve a drug developed by the German drugmaker. Earlier this month, the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), refused Merck's application for approval of the use of Erbitux (cetuximab) in combination with platinum-based chemotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, advanced or metastatic non-small cell lung cancer (NSCLC).

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