key messages from the Gilenya assessment

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Anonymous

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"Overall, the CHMP considered that fingolimod exhibits a heterogeneous and complex safety profile. Safety concerns of fingolimod include bradycardia, AV- blocks, leukopenia, risk of increased frequency and seriousness of infections, occurrence of lymphoma related to its immunosuppressant effect, as well as neurological manifestations including Posterior reversible Encephalopathy Syndrome (PRES), which could be due to the drug itself or the immune suppression. A risk of liver toxicity and strong signals of teratogenicity are also part of this unfavourable safety profile.

Thus, the CHMP was of the opinion that the benefit risk balance [...] was negative."
 
























Anonymous said:
This is from the Assessment Report at the time of registration a year ago and it doesn't mean a thing for the current investigations. Europe restricted the indication to make the benefit risk assessment favorable. http://www.ema.europa.eu/docs/en_GB...ssessment_report/human/002202/WC500104529.pdf
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With all the known and novel safety and toxicity issues this means a restriction to zero to make the risk-benefit assessment favorable. Gilenya will be pulled. The quality of the submitted data isn't very helpful either.
 






Anonymous said:
With all the known and novel safety and toxicity issues this means a restriction to zero to make the risk-benefit assessment favorable. Gilenya will be pulled. The quality of the submitted data isn't very helpful either.
Click to expand...

Do you mean the quality of the submitted data submitted for the recent death?
 






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