Health Care Professionals

OUR MEDICINES

Santhera is passionate about medical science and about developing new medical treatments for patients with orphan and other diseases with high unmet medical needs. Our focus is on the development of therapies for rare neuro-ophthalmological, neuromuscular and pulmonary diseases.

Raxone in LHON

In September 2015, we received European Marketing Authorization for Raxone in the treatment of patients with Leber's hereditary optic neuropathy (LHON). This makes Raxone (idebenone 150 mg) the first and only medicine approved for this condition. Indeed, it is the first medicine approved for any mitochondrial disorder: a major milestone in addressing the unmet medical need represented by this group of rare diseases.

▼The European Medicines Agency (EMA) has indicated that this medicine is subject to additional monitoring.

Our pipeline

Raxone is also being investigated for the treatment of Duchenne muscular dystrophy (DMD). In addition, Santhera’s pipeline includes omigapil, an investigational drug with anti-apoptotic properties, a compound in development to address unmet medical needs for patients with congenital muscular dystrophy (CMD). In February 2018, Santhera in-licensed from Polyphor a clinical stage selective inhibitor (POL6014) of human neutrophil elastase with the potential to treat cystic fibrosis (CF) and other lung diseases.

Access to Raxone

Access for Health Care Professionals to Raxone

Access to Raxone varies by the country from which the order is being placed. Bottles containing 180 tablets of Raxone (idebenone 150 mg) are currently available as follows:

European Union Member States, Norway and Iceland
For availability in one of the countries above please contact order@santhera.com.

Albania, Bosnia and Herzegovina, Kosovo, Montenegro, Republic of Macedonia (F.Y.R.O.M.), Serbia
For availability in these countries please contact Clinigen Group:
E-Mail: global@idispharma.com
Phone: +44 1932 824 123

United States of America
Raxone/idebenone is NOT approved for use in the U.S. and is NOT available for purchase.

Note that Santhera is running a study with idebenone in patients with Duchenne muscular dystrophy (DMD) currently taking steroids that you/your child may be eligible for (see www.siderosDMD.com). For additional information regarding this ongoing trial, please email john.karafilidis@santhera.com.

Santhera provides access to the investigational medicine idebenone for eligible patients 10 years of age and older with DMD through a U.S. Expanded Access Program (EAP) referred to as BreatheDMD, consistent with Santhera Pharmaceutical USA's policy on offering compassionate use to investigational medicines. Details regarding this EAP, including eligibility requirements, ca be obtained by visiting thr website www.breatheDMD.com.

For medical inquiries regarding idebenone, please call: +1 800 887 6915.

All other countries not included above
For availability in all other countries not included above please contact Masters Speciality Pharma: 
Email: orders@masters-sp.com
Phone: +44 208 327 0900 
Fax: +44 208 327 0901 
Online: www.masters-sp.com