A community update about vamorolone in North America
Drug company Santhera Pharmaceuticals, which manufacturers vamorolone, has announced today that it has licensed vamorolone to Catalyst Pharmaceuticals in North America (the US, Canada and Mexico).
This exclusive licence and collaboration agreement means that Catalyst will now manage and distribute vamorolone, a new treatment for the symptoms of Duchenne muscular dystrophy (DMD), in North America.
Vamorolone in the UK
This agreement will have no impact on vamorolone in the UK. Santhera will continue to drive the approval and market access to vamorolone in Europe and in the UK.
In the UK, vamorolone is under review by the Medicines and Healthcare products Regulatory Agency (MHRA).
The National Institute for Health and Care Excellence (NICE), the regulator responsible for assessing the clinical and cost effectiveness of drugs in England, has launched a health technology assessment (HTA) for vamorolone. This is to decide if it is clinically effective and cost effective for NHS patients.
Vamorolone in the US
A new drug application (NDA) for vamorolone in DMD is currently under review in the US by the Food and Drug Administration (FDA).
You can read the Santhera press release about it here.
If you have any questions about this, you can email us at [email protected].