dm+d

Unassigned

New Medicines

Nouryant (EU), Nourianz (US) Parkinson's disease

Information

Nouryant (EU), Nourianz (US)
New molecular entity
Kyowa Kirin
Kyowa Kirin

Development and Regulatory status

None
Not recommended for approval (Negative opinion)
Launched
Nov 21After re-examining its initial opinion, the EMA has confirmed its recommendation to refuse marketing authorisation for the medicine Nouryant [16].
Sep 21 Kyowa Kirin request a re-examination of CHMP opinion [15].
Jul 21EMA CHMP issues a negative opinion recommending refusal of the marketing authorisation for Nouryant. The Agency considered that the results of the studies were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant. The Agency also noted that no effect was seen in the two studies that included patients from EU populations, including the most recent study which involved patients who were receiving the maximum and optimal treatment for their Parkinson’s disease [14].
Jan 20MAA for istradefylline as an adjunctive treatment to levodopa-based regimens in adult patients with Parkinson´s disease (PD) experiencing "OFF" time, has been validated by the EMA and is now under review [12].
Oct 19Launched in US [11].
Aug 19Approved in US as add-on therapy to levodopa/carbidopa to treat ‘off episodes’ in adults with PD. Approval is based on four 12-week placebo-controlled RCTs (n=1,143) that all showed patients treated with istradefylline experienced a statistically significant decrease from baseline in daily "off" time compared to patients receiving a placebo [8].
Feb 08US non approvable letter (5)
May 07Filed in US (4).
Sep 06PIII trials completed in US and EU. Company plan to file in US late 06 (1). US filing postponed to Spring 07 due to request for non-clinical data (3).

Category

Adenosine A2A antagonist
Parkinsons disease typically develops between the ages of 55 and 65 years and occurs in 1-2% of people over the age of 60 years, rising to 3.5% at age 85-89 years. About 0.3% of the general population is affected, and the prevalence is higher among men than women, with a ratio of 1.5 to 1 [10].
Parkinson's disease
Oral

Further information

Yes

Trial or other data

Nov 20Top-line data from the global PIII 6002-014 trial of istradefylline in patients with PD (NCT01968031) demonstrated that the trial did not meet its primary endpoint. A trend towards greater reduction in the daily off-time compared with placebo was observed in the 20mg and 40mg istradefylline groups throughout the evaluation period [13].
Nov 20An analysis of three 12-16 week PIII trials in patients with PD experiencing wearing-off symptoms showed that in one study, treatment with istradefylline was associated with a significant reduction in the percentage of awake time spent in the off state vs. placebo. In the two other studies, istradefylline did not produce a significant reduction in off time vs. placebo, but did produce a statistical trend towards improvements in motor functions scores [13].
Oct 16Kyowa Kirin have completed a PIII, 12-week study (n=613) evaluating efficacy of istradefylline 20 and 40 mg/day (NCT01968031) [9].
Jun 09III double-blind 12 week study (NCT00955526) began comparing istradefylline vs placebo in 360 patients. The primary endpoint is the reduction in the mean total hours of awake time per day spent in the OFF state. Estimated completion date: May 2011. A non-randomised, open label, uncontrolled safety PIII study (NCT00957203)
Sep 06First in class (2).

Evidence based evaluations