Santhera’s Agamree (vamorolone) Receives the US FDA’s Approval for the Treatment of Duchenne Muscular Dystrophy (DMD)
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- The approval was granted based on the data from the P-IIb (VISION-DMD) clinical trial evaluating the safety & efficacy of Agamree (2-6mg/kg/day) vs SoC corticosteroids in patients with DMD for up to 48mos. across 32 clinical trials in 11 countries
- As per the agreement between Santhera & Catalyst Pharmaceuticals, following the approval, Santhera will receive $36M ($10M as milestone payments + $26M to cover contracted third-party milestone obligations) from Catalyst. Additionally, the US marketing authorization of Agamree will be transferred to Catalyst which expects to launch Agamree across the US in Q1’24
- Santhera also received a positive opinion from the CHMP for which the EMA approval is expected by YE 2023
Ref: Santhera | Image: Santhera
Related News:- Santhera Receives the EMA’s CHMP Positive Opinion of Agamree (vamorolone) for the Treatment of Duchenne Muscular Dystrophy
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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.
