After re-examining the initial recommendation back in July, the European Medicines Agency (EMA) has reiterated its recommendation to refuse marketing authorization for istradefylline (Nouryant, Kyowa Kirin) designed to treat Parkinson’s disease (PD).
Istradefylline, an effective adenosine A 2A receptor antagonist, has been approved in the United States (tradename Nourianz) as an add-on treatment for levodopaor carbidopa for adults with PD experiencing “off” episodes.
The initial study of istradefylline included eight studies that involved 3245 patients suffering from PD. The EMA declared in the statement that the results were not consistent and did not prove that the drug decreased the “off” time.
Only four out of the eight studies showed a decrease in “off” time, and the effect did not increase with an increase in dose of istradefylline. The EMA also observed no effects in two studies conducted with patients from the European Union.
After re-examining the evidence, EMA concluded that istradefylline’s benefits were not greater than its risks. The EMA recommended that the drug not be granted marketing authorization.
Content Source: https://www.medscape.com/viewarticle/963040?src=rss