Santhera Pharmaceuticals Holdings AG (SANN.SW), a specialty pharmaceutical company, announced on Monday receipt of a positive opinion from the committee for medicinal products for human use (CHMP), authorizing the age expansion for AGAMREE in treating Duchenne's muscular dystrophy.
Duchenne's muscular dystrophy (DMD) is a rare, neuromuscular disorder that leads to severe, progressive muscular dystrophy. As an X-linked genetic disorder, it largely affects males and is currently managed by treating symptoms with anti-inflammatory corticosteroids.
AGAMREE (vamorolone) is a dissociative, novel, corticosteroid that acts by inhibiting nuclear factor kappa-B gene transcription and preventing transactivation of other genes. It previously received approval by the U.S. Food and Drug Administration (FDA) in 2023 and is marketed for the treatment of DMD in the European Union, UK, Switzerland, Canada, China, and Hong Kong.
AGAMREE has received approval by the European Medicines Agency (EMA) for the treatment of DMD in patients aged 4 years and older. The positive opinion received by the European commission (EC) extends market authorization to patients from 2 years of age, indicating that early anti-inflammatory intervention offers better long-term benefits.
SANN.SW closed Friday at 17.08 CHF, up 0.83%.
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