Ipsen's Dysport Receives FDA Approval for Treatment of Pediatric Limb Spasticity in Children Aged Two and Older

On October 8, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that biopharmaceutical company Ipsen announced that its injectable drug Dysport had received FDA approval for the treatment of limb spasticity in children aged two years and older.

Ipsen, founded in 1929 and headquartered in Paris, France, is a biopharmaceutical company with more than 5,700 employees. The company is primarily engaged in the research and development, manufacturing, and sales of new medicines, providing novel treatment options for patients worldwide. Ipsen focuses on developing innovative drugs in key therapeutic areas such as oncology, neuroscience, and rare diseases, while also maintaining a comprehensive healthcare business.

Ipsen was listed on the Euronext Paris stock exchange in December 2005 and currently operates in more than 30 countries and regions worldwide. According to statistics, in 2018, the company exported more than 20 pharmaceutical products to 115 countries and regions, with total sales exceeding €2.2 billion.

Dysport is an injectable formulation of botulinum toxin type A (BoNT-A), stored as a lyophilized powder. The Ipsen research team dedicated itself to isolating and purifying BoNT-A produced by Clostridium botulinum, thereby developing the Dysport injection. This medication is currently the only BoNT-A injectable approved by the FDA for the treatment of spasticity in the upper and lower limbs of children aged two years and older. Reportedly, Dysport was launched in the United States in 2009, initially indicated for the treatment of adult patients with cervical dystonia (CD) and spasticity.

# Infantile SpasmsInfantile spasms are a common neonatal disorder, typically onset during infancy. Patients primarily present with frequent tonic spasms, hypsarrhythmia on electroencephalogram (EEG), and intellectual developmental disabilities. These spasms often impede the development of motor nerves and related systems in children, resulting in abnormal crawling, kneeling, walking, and other activities. Even with long-term rehabilitation training, achieving ideal therapeutic outcomes remains challenging for these patients.

It is estimated that spasticity affects more than 12 million people worldwide, with patients primarily experiencing muscle stiffness or abnormally increased muscle tone. These conditions often interfere with normal motor function, particularly affecting children in their growth and development stages. Clinical trials have demonstrated that Dysport significantly alleviates symptoms such as spasticity in the limbs of pediatric patients.

Kimberly Baldwin, Vice President of Ipsen’s Neuroscience Business Unit and Head of Franchise Operations, stated, “The FDA approval demonstrates Ipsen’s expertise in the field of neurotoxins. We remain committed to advancing clinical treatment and care for patients with spasticity. Clinical trial data targeting upper and lower limb spasticity in pediatric patients indicate that Dysport will serve as an effective therapeutic option for this patient population.”

Ann Tilton, Professor of Neurology and Clinical Neurology at Louisiana State University in the United States, stated, “For physicians, Dysport is a trusted injectable medication. This therapy effectively alleviates spasticity symptoms in both pediatric and adult patients, thereby improving clinical outcomes.”

(Compiled by Xu Xiaoxue)