Commercial launch in Switzerland anticipated in H2 2026
Pratteln, Switzerland, January 15, 2026 - Santhera Pharmaceuticals (SIX: SANN) announces that the Swiss Agency for Therapeutic Products (Swissmedic), has approved AGAMREE (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older.
Dario Eklund, Chief Executive Officer of Santhera, commented: "As a proudly Switzerland-based business, securing Swissmedic approval represents an important achievement, and marks our seventh global marketing approval. We expect to launch AGAMREE in Switzerland later in 2026, in order to ensure timely access to this important therapy for DMD patients in the country."
The Swissmedic approval of AGAMREE was based on the data from the pivotal Phase 2b VISION-DMD study and assessment results from the European Medicines Agency. Following approval, the Company has been granted a 15-year exclusivity period under Swiss orphan drug status. Santhera retains exclusive distribution rights for AGAMREE in Switzerland and anticipates commercial launch in H2 2026, following the completion of national pricing and reimbursement procedures. There are over 200 people affected by DMD in Switzerland, with few treatment options available to them.
About AGAMREE (vamorolone)
AGAMREE is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids but modifying its downstream activity. Moreover, it is not a substrate for the 11-ß-hydroxysteroid dehydrogenase (11ß-HSD) enzymes that may be responsible for local drug amplification and corticosteroid-associated toxicity in local tissues [1-4]. This mechanism has shown the potential to 'dissociate' efficacy from steroid safety concerns and therefore AGAMREE is positioned as a dissociative anti-inflammatory drug and an alternative to existing corticosteroids, the current standard of care in children and adolescent patients with DMD [1-4].
In the pivotal VISION-DMD study, AGAMREE met the primary endpoint Time to Stand (TTSTAND) velocity versus placebo (p=0.002) at 24 weeks of treatment and showed a good safety and tolerability profile [1, 4]. The most commonly reported side effects were cushingoid features, vomiting, weight increase and irritability. Side effects were generally of mild to moderate severity.
Currently available data show that AGAMREE, unlike corticosteroids, has no restriction of growth [5] and no negative effects on bone metabolism as demonstrated by normal bone formation and bone resorption serum markers [6].
? This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
References:
[1] Dang UJ et al..
[2] Guglieri M et al.
[3] Liu X et al.
[6] Hasham et al., MDA 2022 Poster presentation. Link.
About Santhera
Santhera Pharmaceuticals.
AGAMREE is a trademark of Santhera Pharmaceuticals.
For further information please contact:
Santhera
Catherine Isted, Chief Financial Officer: IR@santhera.com
ICR Healthcare: Santhera@icrhealthcare.com
Disclaimer / Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.
# # #
Attachment
- 260115 Santhera Swissmedic approval FINAL Eng (https://ml-eu.globenewswire.com/Resource/Download/e90fad4a-aaef-443b-8fd0-7d3963464d50)
