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New Medicines

RadicavaAmyotrophic lateral sclerosis (motor neurone disease) - oral suspension formulation

Information

Radicava
New molecular entity
Mitsubishi Tanabe
Mitsubishi Tanabe

Development and Regulatory status

None
None
Launched
Yes
Yes
Jun 22Radicava ORS launched in US [12].
May 22Approved in US for treatment of adults with ALS. Radicava ORS is self-administered and can be taken at home. After fasting overnight, Radicava ORS should be taken in the morning orally or through a feeding tube. The oral medication has the same dosing regimen as Radicava—an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods [11].
Nov 21US FDA accept sNDA for priority review [10].
May 20Mitsubishi Tanabe Pharma Europe is planning to make this available in the UK [7].
Apr 20Has fast track status in US. Company is targeting US launch in financial year 2021/22. The product is being developed to provide an alternative dosing administration option for ALS patients, where there is a significant unmet need. Edaravone intravenous formulation is approved for ALS in Japan, Korea, U.S., Canada, Switzerland and China [5].
Dec 19Has orphan drug status in EU & US [3].
Nov 19PIII global trial of oral suspension starts [1]. Note that in EU the CHMP has previously declined to approve the IV formulation (see IV edaravone monograph).

Category

Free radical scavenger that is believed to relieve the effects of oxidative stress, a likely factor in the onset and progression of ALS.
ALS is the most common form of motor neurone disease; annual incidence of about 2 cases per 100,000 population and prevalence is about 5-7 per 100,000 [2].
Amyotrophic lateral sclerosis (motor neurone disease) - oral suspension formulation
Oral

Trial or other data

Apr 22Company announces results of PIII trial NCT04165824 (n=185) at 24 weeks shows edaravone is safe and tolerable long-term in pts with ALS [9]
Sep 21Collection of primary outcome data in PIII study (NCT04165824) now expected to complete Oct 21 [8].
Oct 20PIII study (NCT04165824) has finished recruiting. Collection of data is due to complete Nov 21 [6].
Dec 19PIII study (NCT04165824) is recruiting in the US only at present. The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone over 24 and 48 weeks. Collection of data is due to complete Jun 21 [4].
Nov 19PIII trial of oral formulation (NCT04165824) starts, a global, multi-center open-label study that will evaluate 150 people with ALS across an estimated 65 sites in the U.S., Canada, Europe and Japan over the course of 48 weeks of treatment [1].