Merck withdraws cladribine tablets from approval process
Based on feedback from US regulator
Merck KGaA will no longer seek approvals for its oral multiple sclerosis treatment cladribine.
The German pharmaceutical firm says it has made the decision based on discussions with the US FDA at the end-of-review meeting for the cladribine tablets application.
Merck believes that data from ongoing clinical trials ‘are very unlikely to address the FDA requirements and will not provide a basis for approval’.
The US FDA’s feedback was consistent with that received from the European Medicines Agency (EMA), which confirmed its negative opinion on cladribine earlier this year.
Merck said attempting to fulfill the FDA and the EMA requirements would require a new clinical trial programme, which would take several years to complete.
Stefan Oschmann, head of Merck Serono, said: ‘Considering the time it would take to complete a new clinical trial programme and the significant risk that even a new programme would not result in data sufficient for cladribine tablets’ approval, and taking into account the changing competitive landscape, we have decided not to pursue further the worldwide approval process of cladribine tablets and to focus resources on other projects bringing benefit to patients with multiple sclerosis.’
Merck will continue its r&d activities to further strengthen its multiple sclerosis pipeline, and will continue its product enhancement, educational and patient support activities around Rebif, Oschmann added.
Merck will withdraw the product from Australia and Russia, where cladribine tablets are approved and already available under the trade name Movectro.
The decision to pull cladribine tablets from the market will result in a one-time charge to Merck of €20m, which will be recorded in second quarter financial statements.