Santhera Starts Phase III Study (SIDEROS) with Raxone in Patients with Duchenne Muscular Dystrophy Using Glucocorticoids - Seite 3
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is currently assessing a Marketing Authorization Application (MAA) for Raxone in DMD patients with respiratory function decline who are not taking concomitant glucocorticoids. The indication would include patients who previously were treated with glucocorticoids or in whom glucocorticoid treatment is not desired, not tolerated or is contraindicated. The MAA was submitted as a Type II variation of the company's existing marketing authorization for Raxone for the treatment of visual impairment in patients with Leber's hereditary optic neuropathy (LHON).
About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of orphan
mitochondrial and neuromuscular diseases. Santhera's lead product Raxone is authorized in the European Union, Norway, Iceland and Liechtenstein for the treatment of Leber's hereditary optic
neuropathy (LHON). For Duchenne muscular dystrophy (DMD), the second indication for Raxone, Santhera has filed a Marketing Authorization Application (MAA) in the European Union. In collaboration
with the US National Institute of Neurological Disorders and Stroke (NINDS) Santhera is developing Raxone in a third indication, primary progressive multiple sclerosis (PPMS), and omigapil for
congenital muscular dystrophy (CMD), all areas of high unmet medical need. For further information, please visit the Company's website www.santhera.com.
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Raxone® is a trademark of Santhera Pharmaceuticals.
For further information, contact: Thomas Meier, PhD, Chief Executive Officer Phone +41 61 906 89 64 thomas.meier@santhera.com |
Christoph Rentsch, Chief Financial Officer Phone +41 61 906 89 65 christoph.rentsch@santhera.com |
Daniel Piller, Head Communications Phone +41 61 906 89 26 daniel.piller@santhera.com |
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US investor contact: Hans Vitzthum, LifeSci Advisors, LLC Phone +1 212 915 2568 hans@lifesciadvisors.com |
US Public Relations contact: |