Santhera Pharmaceuticals (SIX: SANN) has announced that Swissmedic, the Swiss Agency for Therapeutic Products, has begun reviewing the marketing authorisation application (MAA) for AGAMREE® (Vamorolone) as a potential treatment for Duchenne muscular dystrophy (DMD).
Santhera has submitted the AGAMREE® marketing authorisation application (MAA) to Swissmedic under Article 13 of the Swiss Therapeutics Products Act (TPA). This procedure allows Swissmedic to consider the results of foreign regulatory authorities’ assessments, such as the EU approval granted in December 2023. This can potentially expedite the review process by leveraging existing evaluations from countries with similar regulatory standards.
The outcome of the Swissmedic review is anticipated in the first half of 2026, with the possibility of an accelerated timeline if the Article 13 procedure is accepted.
Approval from Swissmedic, in addition to existing approvals from the EMA, FDA, and MHRA, would strengthen the potential for AGAMREE® to gain access to other markets through expedited review processes
Submission of AGAMREE for DMD to Swissmedic is an important milestone, following approvals from the U.S. FDA, the European Commission in the EU, and the UK MHRA, in addition to acceptance for priority review from China’s NMPA. We look forward to working closely with Swissmedic to address the high unmet need for improved treatment options for patients suffering from DMD in Switzerland.
Shabir Hasham, MD, Chief Medical Officer of Santhera.
What is AGAMREE (Vamorolone)
AGAMREE is a novel drug that binds to the same receptor as glucocorticoids but exhibits a distinct mechanism of action, modifying downstream activity. Unlike glucocorticoids, AGAMREE is not a substrate for 11-β-hydroxysteroid dehydrogenase (11β-HSD) enzymes, which can amplify local drug effects and lead to corticosteroid-associated toxicity.
This unique mechanism of action has the potential to separate efficacy from steroid-related safety concerns. As a result, AGAMREE is positioned as a dissociative anti-inflammatory drug and a potential alternative to traditional corticosteroids, the current standard of care for children and adolescents with Duchenne muscular dystrophy.
Would you like to know more about Duchenne muscular dystrophy? Increase your knowledge and understanding of Duchenne with our bite-sized science video series.
Section 1 – Facts about Duchenne muscular dystrophy
Section 2 – Signs and Symptoms of Duchenne muscular dystrophy
Section 3 – Diagnosis of Duchenne muscular dystrophy
Section 4 – Crucial Genetic Terminology
Section 5 – Genetics – Blueprint of Duchenne muscular dystrophy
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