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MHRA approves ‘safer’ medicine alternative for rare disease
A new drug has been approved in the UK as a safer alternative to corticosteroids to treat Duchenne muscular dystrophy (DMD).
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Santhera Pharmaceuticals
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Santhera’s Duchenne muscular dystrophy treatment receives Australian orphan drug designation
13 September 2016 | By Niamh Louise Marriott, Digital Content Producer
The Australian Therapeutic Goods Administration (TGA) has granted orphan drug designation to Santhera Pharmaceutical’s idebenone (raxone) for the treatment of Duchenne muscular dystrophy (DMD). The product has already received ODD from European, Swiss and US authorities...
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FDA grants Santhera $246,000 for muscular dystrophy trial
30 August 2016 | By Niamh Louise Marriott, Digital Content Producer
The FDA have granted Santhera an award of $246,000 in support of its ongoing Phase I trial with omigapil (callisto) incongenital muscular dystrophy (CMD)...
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Santhera launches Raxone in its first EU market
2 October 2015 | By Victoria White
Raxone is also the first approved treatment for any mitochondrial disease, a therapeutic area which is in the focus of Santhera...
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EC grants marketing authorisation for Raxone in Leber’s Hereditary Optic Neuropathy
9 September 2015 | By Victoria White
Raxone is the first approved treatment for Leber’s Hereditary Optic Neuropathy, and for a mitochondrial disease, in the EU...
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CHMP recommends granting marketing authorisation to Raxone for the treatment of Leber’s Hereditary Optic Neuropathy (LHON)
26 June 2015 | By Victoria White
CHMP has recommended granting marketing authorisation to Raxone for the treatment of visual impairment in patients with Leber's Hereditary Optic Neuropathy...
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Results from Phase III trial of Raxone/Catena in patients with DMD published
21 April 2015 | By Victoria White
Results of the double-blind placebo-controlled Phase III trial demonstrating efficacy and safety of Raxone/Catena in patients with DMD have been published...
