Santhera: Europe's CHMP Issues Positive Opinion For AGAMREE To Treat Duchenne Muscular Dystrophy

Swiss drug maker Santhera Pharmaceuticals Holding AG (SPHDF.OB) announced Friday that European Commission’s Committee for Medicinal Products for Human Use or CHMP adopted a positive opinion in favor of approval of AGAMREE (vamorolone) to treat Duchenne muscular dystrophy or DMD patients aged 4 years and older.

The European Commission’s decision on marketing authorization is expected within approximately two months of the positive CHMP opinion, in late 2023. Subject to approval, AGAMREE will be the first drug fully approved by the European Medicines Agency for the treatment of patients with DMD, the company noted.

Santhera expects for a first commercial launch in Germany in Q1-2024, subject to approval by the EC.

Santhera noted that the CHMP, in its recommendation for approval, acknowledged the positive benefit-risk profile of AGAMREE in this patient population. It includes certain safety benefits of AGAMREE compared to standard of care corticosteroids in the treatment of DMD.

The clinical evidence for the efficacy and safety of AGAMREE in the regulatory submission was derived from the positive pivotal VISION-DMD study and three open-label studies.

The studies were carried out by Santhera’s partner ReveraGen and 32 academic clinical trial centers in 11 countries. In the pivotal VISION-DMD study, boys treated with vamorolone on average maintained growth similar to those treated with placebo, whilst those treated with prednisone on average experienced growth stunting.

Patients who switched from prednisone to vamorolone after 24-weeks were, on average, able to resume growing in height over the remainder of the study.

Santhera said it will continue to collect data to further characterize the long-term effectiveness and safety differentiation of vamorolone.

In the U.S., FDA established the target Prescription Drug User Fee Act (PDUFA) action date for its regulatory decision on the vamorolone NDA as October 26, 2023. Subject to approval, Santhera’s licensing partner Catalyst Pharmaceuticals plans to launch vamorolone in the U.S. in Q1-2024.

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