Swissmedic marketing authorization number: 67251
Swissmedic first marketing authorization date: 06.05.2021
1.
Indication: 5q-associated spinal muscular atrophy (SMA)
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 SMA patients
Sponsor: F. Hoffmann-La Roche Ltd
2.
Indication: 5q-associated spinal muscular atrophy (SMA)
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 SMA
Sponsor: F. Hoffmann-La Roche Ltd
3.
Indication: 5q-associated spinal muscular atrophy (SMA)
Phase: II
Summary: An open-label study to investigate the safety, tolerability and pharmacokinetics/pharmacodynamics of risdiplam (RO7034067) in adult and pediatric patients with SMA
Sponsor: F. Hoffmann-La Roche Ltd
4.
Indication: 5q-associated spinal muscular atrophy (SMA)
Phase: II
Summary: An open-label, single-arm, multicenter clinical study to investigate the efficacy, safety, pharmacokinetics, and pharmacodynamics of risdiplam (RO7034067) in infants from birth to 6 weeks of age (at first dose) who have been genetically diagnosed with SMA but do not yet present with symptoms.
Sponsor: F. Hoffmann-La Roche Ltd
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Please see
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.
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