Pratteln, Switzerland, September 24, 2024 - Santhera Pharmaceuticals (SIX: SANN) announces that Swissmedic, the Swiss Agency for Therapeutic Products, has accepted for review the marketing authorization application (MAA) for AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD).
Santhera asked Swissmedic to assess AGAMREE® as part of Article 13 TPA (therapeutics product act) procedure, allowing it to consider the results of foreign regulatory authorities' assessments when reviewing a medicinal product for authorization in Switzerland. In the case of AGAMREE, Swissmedic will consider the EU approval of the drug received in December 2023. This can streamline the approval process by leveraging existing evaluations from countries with comparable regulatory standards. The outcome of the Swissmedic review is expected in late H1-2026 with the possibility to be accelerated to early 2026 if the Article 13 is accepted. Swissmedic approval in addition to EMA/FDA/MHRA approvals will leverage the access for this orphan drug to other markets through an abbreviated review.
"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," commented Shabir Hasham, MD, Chief Medical Officer of Santhera. "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."
About AGAMREE®), the European Union) and the United Kingdom.
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 Duchenne Muscular Dystrophy
Duchenne muscular dystrophy (DMD) is a rare inherited X-chromosome-linked disease, which almost exclusively affects males. DMD is characterized by inflammation which is present at birth or shortly thereafter. Inflammation leads to fibrosis of muscle and is clinically manifested by progressive muscle degeneration and weakness. Major milestones in the disease are the loss of ambulation, the loss of self-feeding, the start of assisted ventilation, and the development of cardiomyopathy. DMD reduces life expectancy to before the fourth decade due to respiratory and/or cardiac failure. Corticosteroids are the current standard of care for the treatment of DMD.
About Santhera
Santhera Pharmaceuticals.
AGAMREE® is a trademark of Santhera Pharmaceuticals.
For further information please contact:
public-relations@santhera.comor
Eva Kalias, Head Investor Relations & Communications
Phone: +41 79 875 27 80
eva.kalias@santhera.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.
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