Santhera Reports MHRA’s Approval of Agamree (Vamorolone) to Treat Duchenne Muscular Dystrophy
Shots:
- Followed by approval from the US FDA and EC for the treatment of DMD in patients aged 2yrs. in the US and 4yrs. & older in the EU, MHRA has approved Agamree (dosing b/w 2 and 6mg/kg/day, for total of 30mos.) based on results from the (VISION-DMD) and 3 other trials
- The results showed that Agamree neither reduced bone metabolism nor bone mineralization in the spine after 48wks. and recovered growth & bone health after switching from SoC corticosteroid. Additional data is being collected for its efficacy and safety
- Vamorolone targets the same receptor as glucocorticoids, modifying downstream activity. It does not bind to 11-β-hydroxysteroid dehydrogenase enzymes responsible for local tissue amplification and associated toxicity
Ref: Santhera | Image: Santhera
Related News:- Santhera’s Agamree (vamorolone) Receives the US FDA’s Approval for the Treatment of Duchenne Muscular Dystrophy (DMD)
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
