Evrysdi®

EVRYSDI ® (Risdiplam), powder for oral solution at 0.75 mg risdiplam/ml
Swissmedic marketing authorization number: 67251
Swissmedic marketing authorization date: 06.05.2021

Marketing authorization studies (3):

1. SUNFISH (BP39055)

Indication:

Phase: II/III

Summary: A two-part seamless, multi-center randomized, placebo-controlled, double- blind study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy patients

Sponsor: F. Hoffmann-La Roche Ltd

2. FIREFISH (BP39056)

Indication:

Phase: II/III

Summary: A two-part seamless, open-label, multi-center study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of risdiplam (RO7034067) in infants with Type 1 Spinal Muscular Atrophy

Sponsor: F. Hoffmann-La Roche Ltd

3. JEWELFISH (BP39054)

Indication:

Phase: II

Summary: An open-label study to investigate the safety, tolerability and pharmacokinetics/pharmacodynamics of risdiplam (RO7034067) in adult and pediatric patients with Spinal Muscular Atrophy

Sponsor: F. Hoffmann-La Roche Ltd


Publication of the results of clinical trials
The information given above and the links to the clinical data fulfil the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO) and amend the information published in association with the Swiss marketing authorization for Evrysdi. Articles 71- 73 TPO apply to all medicinal products that were submitted as of January 2019 and were granted marketing authorization by Swissmedic. The published data will help doctors and other healthcare service providers to take well-informed decisions on treatment and allow researchers to more easily build on the research carried out by Roche and its partners, as well as that carried out by other researchers, to ensure continued scientific progress.