FDA Accepts Ipsen's BLA For Dysport To Treat Upper Limb Spasticity
By Cyndi Root
Ipsen Biopharmaceuticals announced in a press release that the Food and Drug Administration (FDA) has accepted its supplemental Biological License Application (sBLA) for Dysport (abobotulinumtoxinA). Currently, the agent is approved for cervical dystonia, and the sBLA seeks an indication for the treatment of upper limb spasticity in adults. Dysport is approved for spasticity in several markets worldwide. Marc de Garidel, Chairman and CEO of Ipsen stated, “The filing of Dysport in adult upper limb spasticity is an important step in the reinforcement of the U.S. neurology franchise.”
Dysport
Ipsen is seeking FDA approval for Dysport in treating upper limb spasticity, which can occur after a stroke, spinal cord injury, traumatic brain injury, or due to multiple sclerosis (MS) or cerebral palsy. Dysport is botulinum toxin type A (BoNT-A), derived from Clostridium BoNT-A bacteria. The product is a lyophilized powder reconstituted for injection. The agent launched in 1990 for the treatment of blepharospasms and hemifacial spasms. In 75 countries, the agent is prescribed for various conditions, including pediatric lower limb spasticity due to cerebral palsy (CP), axillary hyperhidrosis, and glabellar lines.
To support its application, Ipsen conducted a Phase 3 study with 243 adult patients with upper limb spasticity. The international, multi-center, placebo-controlled trial evaluated Dysport in hemiparetic patients following stroke or brain trauma. Dysport patients showed a statistically significant improvement in muscle tone as measured by the Modified Ashworth Scale (MAS). Additionally, according to the Physician Global Assessment (PGA), Dysport patients showed a better clinical benefit profile than the placebo patients.
Ipsen Activities
Ipsen is headquartered in Paris, France where it focuses on treatments for neurology, endocrinology, and uro-oncology diseases. The company is active in partnering, and its R&D efforts focus on novel platforms, peptides, and toxins. In November 2014, Ipsen renewed its collaboration with the Salk Institute for Biological Studies for another three years. They intend to expand their work in modified viruses, pluripotent stem cell neurons, and tumor cell interaction with the tissue microenvironment.
Also in November, Ipsen and Otonomy entered into an exclusive licensing agreement regarding Otonomy’s OTO-31, a formulation of gacyclidine, in the treatment of tinnitus. The arrangement allows Otonomy to use Ipsen’s data on gacyclidine, allowing Otonomy to initiate clinical trials in 2015.