Raxone

June 27, 2018June 27, 2018

UK Agency Renews Early Access Program for Raxone to Treat Duchenne MD

News

People with Duchenne muscular dystrophy (DMD) in the U.K. will continue to have access to Raxone (idebenone) to treat their disease, after the Medicines and Healthcare products Regulatory Agency (MHRA) renewed its ... Read more

February 23, 2018February 23, 2018

Duchenne MD Patients with Respiratory Decline Gain Access to Raxone in US

News

The investigational treatment Raxone (idebenone) could become available to qualifying Duchenne muscular dystrophy (DMD) patients in the U.S. with respiratory decline following the start of an expanded access program ... Read more

February 7, 2018

Santhera Making Raxone Available to DMD Patients in US Under Expanded Access Program

News

Santhera Pharmaceuticals recently launched an expanded access program (EAP) to allow certain Duchenne muscular dystrophy (DMD) patients in the U.S. to gain access Raxone (idebenone). Raxone is not approved to treat Duchenne MD ... Read more

January 29, 2018January 29, 2018

European Agency Again Recommends Against Approval of Raxone as DMD Therapy

News

An advisory committee of the European Medicines Agency (EMA) has issued another negative recommendation after re-examining a request to extend Raxone (idebenone) for use in treating Duchenne muscular dystrophy (DMD). The EMA’s ... Read more

September 15, 2017

Santhera to Appeal European Agency’s Decision Against Raxone as a Duchenne MD Therapy

News

The agency that plays the key role in European Union therapy authorizations has recommended against approval of Raxone (idebenone) as a Duchenne muscular dystrophy (DMD) treatment. Santhera said in a press release that it plans to ... Read more

September 12, 2017September 19, 2017

First DMD Patients to Receive Raxone Under U.K.’s Early Access Program

News

The first patients with Duchenne muscular dystrophy (DMD) have been enrolled into the U.K.’s Early Access to Medicines Scheme (EAMS) for Santhera Pharmaceuticals’ Raxone (idebenone), giving patients access to ... Read more

June 23, 2017

UK Agency Grants Raxone Temporary Approval to Treat Certain DMD Patients

News

Raxone (idebenone) has been granted temporary scientific approval to be used to treat certain patients with Duchenne muscular dystrophy (DMD) in the United Kingdom (UK). The UK’s Medicines and ... Read more

May 22, 2017

European CHMP Continues to Support Development of Raxone in Duchenne MD

News

Santhera Pharmaceuticals has updated the timeline for the ongoing assessment by the European Committee for Medicinal Products for Human Use (CHMP) of its Duchenne muscular dystrophy (DMD) drug, Raxone ... Read more

February 24, 2017February 24, 2017

Phase 3 Study of Raxone on Respiratory Health of DMD Patients Using Glucocorticoids Opening in US, Europe

News

Santhera Pharmaceuticals is recruiting patients for a new Phase 3 clinical trial evaluating its lead candidate Raxone (idebenone) in slowing respiratory decline in Duchenne muscular dystrophy (DMD) patients being treated with glucocorticoids. ... Read more

September 15, 2016September 15, 2016

Potential DMD Treatment, Raxone, Designated ‘Orphan Drug’ by Australian Regulators

News

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has granted Santhera Pharmaceuticals’ lead product Raxone (idebenone) orphan drug designation for the treatment of Duchenne muscular dystrophy (DMD). Raxone ... Read more

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