Breaking News, Trials & Filings

Merck Serono Abandons Cladribine

Cancels NDA and MAA and withdraws MS treatment from approved markets

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Merck Serono, a division of Merck KGaA, has decided to cease pursuing approval of Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS). Based on discussions with the FDA at the end-of-review meeting for Cladribine Tablets’ new drug application, the company concluded that data from ongoing clinical trials are very unlikely to address the FDA requirements and will not provide a basis for approval. The company will also withdraw the product from Russia and Austr...

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