Merck Germany, announced today that after discussing Cladribine, a treatment of relapsing-remitting multiple sclerosis (MS) with international organizations including the FDA, it will halt approval attempts of the prescription realizing it would never pass global clinical trials and simply was not worth the spend.
Dr. Bernhard Kirschbaum, Merck Serono’s Head of Research and Development explain they will continue the current research however for the sake of current human participants:
“We are extremely grateful for the strong support we have received from patients and from physicians during the whole clinical development of Cladribine Tablets. We intend to complete the core 96-week duration of the ongoing clinical trials with Cladribine Tablets in order to provide study participants with the opportunity to continue the trials and to add knowledge for the scientific community.”
Overall the FDA feedback was consistent with the feedback previously received from the European Medicines Agency (EMA). Attempting to fulfill the FDA and the EMA requirements would necessitate the initiation of a new clinical trial program which would take several years to complete.
Dr. Stefan Oschmann, President of Merck Serono continues:
“Considering the time it would take to complete a new clinical trial program and the significant risk that even a new program would not result in data sufficient for Cladribine Tablets’ approval, and taking into account the changing competitive landscape, we have decided to not pursue further the worldwide approval process of Cladribine Tablets and to focus resources on other projects bringing benefit to patients with multiple sclerosis. We will continue our research and development activities and will actively pursue in-licensing opportunities to further strengthen our pipeline in multiple sclerosis, and we will also continue our product enhancement, educational and patient support activities around Rebif, to address relevant medical needs for patients with this devastating disease.”
Some brands of Rebif however contain albumin made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that one may get infections from the medication (for example viruses such as hepatitis).
Merck Serono intends to withdraw applications from regulatory review in the limited number of countries where procedures are ongoing.
In Australia and Russia, where Cladribine Tablets are approved and available under the trade name Movectro, Merck intends to withdraw the product from the market and will discuss the timelines and other details with the local regulatory agencies to determine the best solutions for patients currently on Movectro therapy.
It is estimated that approximately two million people have MS worldwide.
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
Source: Merck Serono, a division of Merck KGaA
Written by Sy Kraft