Europe committee rejects MS treatment Movectro
pharmafile | September 24, 2010 | News story | Sales and Marketing | Cladribine, Merck Serono Movectro
The Europe Medicines Agency has rejected Merck Serono’s new multiple sclerosis treatment Movectro, saying its benefits do not outweigh its risks.
The news is a significant setback for the company, which is also awaiting a decision from US officials at the FDA, and follows good news earlier in the week for a rival treatment, Novartis’s Gilenya (fingolimod), which was approved in the US.
Merck Serono’s Movectro (cladribine) has already been approved in Russia and Australia for relapse and remitting multiple sclerosis.
Movectro and Gilenya are both new oral treatments which promise to help reduce the number of disabling attacks of the disease experienced by patients with ‘relapsing and remitting’ MS.
The reasons for the negative EMA decision on Movectro have not yet been released, but regulatory advisors at the CHMP are thought to have been concerned about four cancer cases seen in its clinical trials, as well as the drug’s effect of suppressing the immune system.
Merck Serono’s president Elmar Schnee told Bloomberg in a telephone interview: “It’s a sad day for MS patients in Europe, I’m really surprised at the verdict.”
Merck Serono says it is evaluating all options to gain approval in the Europe, including a potential appeal to request re-examination of the submission by the CHMP, and Elmar Schnee said it would do everything it could to gain the key approval.
“With the considerable support of the multiple sclerosis community and backed by the recent approvals in Australia and Russia, we will continue to work with the CHMP to address the committee’s concerns and pursue a way forward to make cladribine tablets available to patients from the European Union.”
“Multiple sclerosis is a heterogeneous disease and currently available treatments do not meet the medical needs of all patients with active disease,” said Professor Gavin Giovannoni, Blizard Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry, London, United Kingdom, and principal investigator of Merck Serono’s CLARITY study.
“As a clinician, I hope that a way forward will be found to allow people suffering from this devastating disease to have the option of benefiting from cladribine tablets therapy.”
The drug is undergoing a priority review in the US, but has been delayed. Most notably, the FDA issued it with a ‘refuse to file’ letter in November 2009, indicating the submission was considered incomplete.
Despite the setbacks, Merck Serono still hope the drug can achieve blockbuster sales in excess of $1billion.
Andrew McConaghie
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