Santhera Confident Of Raxone DMD Success Despite Setbacks

The Swiss company believes it has collected sufficient new data on Raxone for Duchenne muscular dystrophy to convince regulators and hopes to file for that indication on both sides of the Atlantic by the end of the first quarter of 2019.

Fingers crossed
Santhera hopes for better luck with regulators • Source: Shutterstock

Santhera Pharmaceuticals AG is still convinced that there is a future for Raxone (idebenone) as a treatment for Duchenne muscular dystrophy (DMD) despite repeated knockbacks from European regulators, as sales of the drug in its already-approved indication of Leber’s hereditary optic neuropathy (LHON) continue to climb.

The Swiss drugmaker has had a tough time to date in its talks with the European Medicines Agency with the...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Rare Diseases

More from Scrip

China Signals Restarting IPOs For Unprofitable Biotechs

 

The China Securities Regulatory Commission has proposed a new “growth tier” for the STAR Market of the Shanghai Stock Exchange, to reinstate the market’s listing standards for unprofitable firms.

BIO Notebook: Woodcock Calls For Doing The Right Thing, Dealmaking Remains Constrained

 

Highlights from Day Four of the BIO International Convention include Woodcock offering practical advice on rare disease trials, the sorry state of dealmaking mid-year, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.

Syncona Looks To Go Private As Market Decline Deepens

 

While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.