Friday, 21 January 2011

A no for oral cladribine in Europe

The European Medicines Agency confirmed its previous negative opinion and adopted a final negative opinion, recommending that oral cladribine, from Serono Europe Ltd, should not be granted a marketing authorisation. Oral cladribine was intended as disease-modifying therapy in relapsing remitting multiple sclerosis.

Click here for EMA statement

Thumbs down for fampridine

European Medicine's agency gives a negative opinion for fampridine:

"The Committee adopted a negative opinion recommending that fampridine, from Biogen-Idec Ltd, should not be granted a marketing authorisation. Fampyra was intended to be used to improve the walking ability of adult patients with multiple sclerosis."

Where to next?

Click here for EMA notification

Fingolimod licensed in Europe

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that:

Fingolimod is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following adult patient groups:

Patients with high disease activity despite treatment with a beta-interferon. These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon. Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gadolinium-enhancing lesion. A “non-responder” could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year.

OR

Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Click here for summary report

Thursday, 20 January 2011

Safety and tolerability of cladribine tablets in MS

A more detailed analysis of the safety of cladribine has just been published. Unfortunately, it is too early to comment on the malignancy risk; this will require long-term follow-up and an active post-marketing surveillance programme.

Cook et al. Mult Scler. 2011 Jan 12. [Epub ahead of print]

Disclaimer: As the principal investigator on this study I have an obvious conflict of interest.

Sleep disorders and fatigue in MS: evidence for association and interaction

Fatigue is very common in MS and can be attributed to many factors. This paper reviews sleep disturbances in MS and it association with fatigue. In people with significant fatigue sleep hygiene should be on top of the management plan; without a good night's sleep how can you expect to feel awake and full of energy.

Kaminska et al. J Neurol Sci. 2011 Jan 15. [Epub ahead of print]

Relationship between global cognitive decline and depressive symptoms in MS

Cognitive symptoms and depression are common in people with MS. A recent study shows an association between these symptoms; subjects with cognitive impairment were more likely to report low mood.

Barwick FH, Arnett PA. Clin Neuropsychol. 2011 Jan 12:1-17.