Pratteln, Switzerland, and Rockville, MD, USA – Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc (US: private) announce positive key results from the VISION-DMD study, demonstrating robust efficacy across multiple efficacy endpoints and favorable safety and tolerability of vamorolone in the treatment of patients with DMD. VISION-DMD is a pivotal...
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Pratteln, Switzerland – Santhera Pharmaceuticals (SIX: SANN) today notes that Health Canada has approved AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older following Priority Review, marking the first approved treatment for the disease in Canada. The Canadian Neuromuscular Disease registry estimates...
Santhera Announces Completion of First 6-Month Period of Pivotal VISION-DMD Trial with Vamorolone in Duchenne Muscular Dystrophy Pratteln, Switzerland Santhera Pharmaceuticals (SIX: SANN) announces that the last patient has completed the last visit for the first period of the placebo-controlled pivotal VISION-DMD study with vamorolone in patients with Duchenne muscular...
Pratteln, Switzerland – Santhera Pharmaceuticals (SIX: SANN) announces that the China National Medical Products Administration (NMPA) has accepted for priority review the new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) which was submitted by Sperogenix Therapeutics, Santhera’s specialized rare disease partner for China. The Center for Drug...
Pratteln, Switzerland – Santhera Pharmaceuticals (SIX: SANN) announces positive topline results from its long-term Phase 4 LEROS study with Raxone® (idebenone) in the treatment of Leber’s hereditary optic neuropathy (LHON). The primary endpoint, proportion of eyes with clinically relevant benefit after 12 months treatment with Raxone versus untreated patients from an...
Pratteln, Switzerland – Santhera Pharmaceuticals (SIX: SANN) announces positive results from its multiple ascending dose Phase 1b study with lonodelestat, a potent inhibitor of human neutrophil elastase (hNE), in patients with cystic fibrosis (CF). Lonodelestat is a potent and selective peptide inhibitor of human neutrophil elastase (hNE), currently being developed...
Pratteln, Switzerland – Santhera Pharmaceuticals (SIX: SANN) announces the publication of the paper “Efficacy and Safety of Vamorolone Over 48 Weeks in Boys With Duchenne Muscular Dystrophy” in the peer-reviewed journal Neurology. The publication reports the results of the 48-week treatment with vamorolone in patients with DMD in the VISION-DMD...
Pratteln, Switzerland – Santhera Pharmaceuticals (SIX: SANN) today reported positive topline results from an analysis of long-term data, including first assessments from the ongoing, open-label, multicenter GUARDIAN study evaluating AGAMREE® (vamorolone) in patients with Duchenne muscular dystrophy (DMD). The long-term analysis included corticosteroid-naïve patients who began AGAMREE treatment between four and...
Pratteln, Switzerland — Santhera Pharmaceuticals (SIX: SANN) announces that has submitted a marketing authorization application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). In parallel to the MAA submission to the UK MHRA, Santhera is currently preparing...
Pratteln, Switzerland – The European Commission (EC) granted marketing authorization to vamorolone for the treatment of patients with Duchenne muscular dystrophy (DMD), who are 4 years of age and above, according to a press release from Santhera, the developers of the treatment. Vamorolone will be sold under the brand name...