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CHMP Recommends Cladribine (Mavenclad) for MS

















































Image Source: IMGARCADE

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of cladribine (Mavenclad, Merck Serono Europe Ltd) for treatment of adults with highly active relapsing MS as defined by clinical or imaging features.

Cladribine is an antimetabolite that depletes lymphocytes by causing DNA strand breaks and interfering with DNA synthesis. Cladribine has been shown to reduce the frequency of relapses and to delay disease progression. The oral drug will be available as 10-mg tablets.

The most important side effects are lymphopenia, which can be severe and long-lasting, the EMA statement notes, and infections, including herpes zoster.
Cladribine for MS has had a rocky road. A new drug application was rejected by European regulators in 2010 and by the US Food and Drug Administration in 2011. The agencies cited concerns about a signal of cancer risk in the initial results of the phase 3 CLARITY trial.

However, recent post hoc analysis of CLARITY and CLARITY Extension showed that with cladribine treatment, depending on cumulative dose, up to 90% of patients were free of new lesions on MRI and up to 81% remained relapse-free after 4 years.

Especially important for this agent, the analysis raised no long-term safety concerns. 

The data were presented at the Consortium of Multiple Sclerosis Centers 2017 Annual Meeting in June and were reported by Medscape Medical News.
The EMA advised that cladribine treatment be initiated and supervised by a physician experienced in the treatment of MS.


Story Source: The above story is based on materials provided by MEDSCAPE
Note: Materials may be edited for content and length

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