Raxone

August 8, 2018August 8, 2018

Arizona Woman with Duchenne is a Rarity Among the Rare

News

Duchenne muscular dystrophy affects an estimated 1 in 3,500 male births. But Elizabeth Heller is an outlier even among her rare friends. The Chicago-born Heller, who relocated to Tempe, ... Read more

July 23, 2018July 23, 2018

Raxone Delays Assisted Ventilation in DMD Patients by 3 Years, Phase 3 Trial Results Show

News

Treatment of Duchenne muscular dystrophy (DMD) patients with Raxone (idebenone) delays the need for assisted ventilation by three years, new data from a Phase 3 clinical trial show. Trial ... Read more

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

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