BRIEF—Raxone reimbursed in France again

Swiss rare disease company Santhera Pharmaceuticals has secured a final reimbursement agreement with the French authorities for its Leber's hereditary optic neuropathy (LHON) therapy Raxone (idebenone).

The permanent scheme replaces a temporary reimbursement agreement, which was withdrawn in August 2021. Since that time, the firm has continued to provide treatment to LHON patients free of charge.

Santhera said it would also submit a request in France, “in the near-term,” for an early access program in Duchenne muscular dystrophy (DMD).

The new agreed price is lower than before, and Santhera has agreed to make repayments totalling 25 million euros ($27 million), in two tranches from 2024.

Subject to approval in the USA, Santhera plans to launch vamorolone in the final quarter of 2023. Outside of France and North America, Santhera has out-licensed Raxone to Chiesi.