Merck Serono’s multiple sclerosis drug on track for filing
pharmafile | January 23, 2009 | News story | Research and Development, Sales and Marketing |Â Â MS, Merck SeronoÂ
Cladribine, a new oral treatment for multiple sclerosis is on track for a mid-2009 filing after the release of encouraging new data.
Merck Serono already markets injectable MS treatment Rebif, but is racing other companies to be the first to launch an effective oral treatment for the condition.
New phase III data from the two year CLARITY study shows the drug produced a 58% relative reduction in relapse rates compared to placebo.
"We believe the CLARITY data mark an important milestone in the assessment of investigational oral treatments for multiple sclerosis, and that cladribine tablets have the potential to make a real difference in the lives of patients," said Elmar Schnee, president of Merck Serono.
"Based on the successful completion of the CLARITY study, we plan to submit cladribine tablets for registration to the EMEA and to the FDA for mid-2009."
The FDA has already indicated that it will fast track cladribine's review because of the highly promising nature of oral therapy for patients with relapsing forms of multiple sclerosis.
Cladribine is a small molecule drug that may interfere with certain white blood cells, particularly lymphocytes, which are thought to be involved in the process of MS.
The CLARITY study also saw the drug meet secondary endpoints, including reduction of lesion activity as measured by magnetic resonance imaging (MRI), the proportion of subjects who are relapse-free and disability progression.
The company reported no worrying side-effects. Lymphopenia (low white blood cell count), an expected side-effect based on cladribine's mechanism of action, was seen more in patients taking the drug, but did not cause concern.
Full results from the study are expected to be released in the coming months.
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