
Santhera gains MHRA approval for Agamree as treatment for Duchenne muscular dystrophy
Betsy Goodfellow | January 12, 2024 | News story | Medical Communications | Agamree, Duchenne Muscular Dystophy, MHRA, Musculo-skeletal disorder, santhera
Santhera Pharmamceuticals has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved Agamree (vamorolone) in the UK for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older.
This UK approval follows an approval in Europe by the European Commission (EC) of the European Medicines Agency (EMA). The EC’s approval was based on data from the VISION-DMD study and three open-label studies in which the drug was administered at doses between 2mg and 6mg/kg/day for up to 30 months.
Shabir Hasham MD, chief medical officer of Santhera, commented: “We are delighted to have secured a third approval for Agamree to treat DMD from a major regulatory agency, after the US Food and Drug Administration (FDA) and EMA, within a couple months. In addition to its anti-inflammatory efficacy, both the EMA and the MHRA recognise the benefits of treatment with Agamree for bone health and growth, underlining the favorable safety and tolerability profile of this novel medicine compared to conventional corticosteroids. We are working towards making Agamree available to patients in the UK in the second half-year 2024, after the National Institute of Health and Care Excellence (NICE) completes its pricing review. Initial European launch will be in Germany in Q1.”
Betsy Goodfellow
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