The UK’s health technology assessor, the National Institute for Health and Care Excellence (NICE) has issued positive Final Guidance that recommends Agamree (vamorolone) for use in the National Health Service (NHS) in England, Wales and Northern Ireland for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older.
Swiss specialty pharma firm Santhera Pharmaceuticals (SIX: SANN), the developer of the drug, noted that this follows confirmation that no appeals were received against the Final Draft Guidance (FDG) recommendation announced in December. Following this, Santhera has already started launch preparations for Agamree in the UK and expect first sales in this quarter.
According to Santhera, Agamree is the first and only medicinal product for DMD to have received full approval in the European Union, USA, and UK. This recommendation follows the Medicines and Healthcare products Regulatory Agency’s (MHRA) approval of Agamree on January 11, 2024, which, alongside the European Medicines Agency (EMA), acknowledged clinically important tolerability benefits with regards to maintaining normal bone metabolism, density, and growth compared to standard of care corticosteroids, alongside similar efficacy from clinical trials.
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