Isotechnika Pharma Inc IPHAF

EMA decision

[tcdrugs]

Only one main study supported the application and the

results did not show in a robust way that Luveniq was more effective than placebo at reducing eye

inflammation, while no difference was seen in the patients’ eyesight compared with placebo. Luveniq

also caused side effects which are known to occur with this type of immunosuppressive medicine,

including hypertension (high blood pressure). Therefore, at that point in time, the CHMP was of the

opinion that the benefits of Luveniq had not been shown to outweigh its risks and recommended that it

be refused marketing authorisation.