Santhera Pharmaceuticals has revealed that AGAMREE (vamorolone) has received approval in the United Kingdom (UK) for treating Duchenne muscular dystrophy (DMD) in patients aged 4 and above, regardless of the underlying mutation and ambulatory status.
The UK’s MHRA, aligning with the European Medicines Agency (EMA), recognized AGAMREE’s clinically significant safety advantages in maintaining normal bone metabolism, density, and growth compared to conventional corticosteroids, while demonstrating comparable efficacy.
Shabir Hasham, MD, Chief Medical Officer of Santhera, stated, “We are delighted to have secured a third approval for AGAMREE to treat Duchenne from a major regulatory agency, after the U.S. FDA and the EU EMA, within a couple of months. In addition to its anti-inflammatory efficacy, both the EMA and the MHRA recognize 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 NICE completes its pricing review. The initial European launch will be in Germany in Q1.”
Santhera will continue to collect data to further characterize the long-term effectiveness and the broader safety differentiation of vamorolone.