Managed Access Program for viltolarsen in patients with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping therapy
Latest Information Update: 07 Dec 2021
At a glance
- Drugs Viltolarsen (Primary)
- Indications Duchenne muscular dystrophy
- Focus Therapeutic Use
- 07 Dec 2021 New trial record
- 29 Nov 2021 According to a Clinigen media release, the company will manage key elements of the program including regulatory oversight, logistics and access management under the terms of the agreement,.
- 29 Nov 2021 According to a Clinigen media release, the company announces that it has signed an exclusive agreement with Nippon Shinyaku to implement a Managed Access Program for viltolarsen for patients with Duchenne muscular dystrophy. After finalization, this program will enable early access to viltolarsen for eligible patients in countries where it is not commercially available.