Dravet syndrome (DS), also known as epilepsy with polymorphic seizures and polymorphic epilepsy in infancy (PMEI), is a severe and rare genetic dysfunction of the brain (epileptic encephalopathy). It usually begins in first year of life and remains throughout lifetime. Children suffering from dravet syndrome suffer from different type of seizures namely, myoclonic seizures, tonic-clonic seizures, absence seizures, atypical absence seizures, atonic seizures, focal aware or impaired awareness seizures (previously called partial seizures), and status epilepticus. Generally, combination of drugs are prescribed for the treatment of Dravet syndrome. Anticonvulsants such as stiripentol, topiramate, and Valproic acid are the most commonly used drugs for treatment of seizures and Dravet syndrome. In cases where intensity of seizures are not reduced by medication, certain devices are used to treat Dravet syndrome. Vagal nerve stimulation device is one such device, which delivers electrical impulses to the vagus nerve.
Dravet Syndrome Treatment Market Drivers
Increasing research & development activities for the development of novel drugs for Dravet syndrome, and subsequently their approval in key regions such as North America and Europe is expected to fuel growth of the global Dravet syndrome treatment market in near future. In 2017, Epygenix Therapeutics, Inc.—a biopharmaceutical company—received U.S. Food and Drug Administration (FDA) orphan drug designation for its EPX-300, indicated for the treatment of Dravet syndrome. In 2017, Ovid Therapeutics—a U.S.-based biopharmaceutical company—received orphan drug designation for TAK-935/OV935 by U.S. Food and Drug Administration (FDA). In February 2018, Zogenix Inc. announced FDA approval of breakthrough therapy designation to ZX-008, its Phase III drug for seizures associated with Dravet Syndrome. In 2017, OPKO Pharmaceuticals LLC, a subsidiary of OPKO Health, Inc., received orphan drug designation from U.S. FDA for its oligonucleotide-based AntagoNAT (CUR-1916) indicated for the treatment of Dravet Syndrome, and the company also received orphan drug designation for its CUR-1916 from European Commission during the same year. Furthermore, strategic collaborations among key players in market for the development and manufacturing of drugs indicated for treatment of Dravet syndrome is also expected to drive growth of the Dravet syndrome treatment market. For instance, in 2017, Laurus Synthesis Inc. and Epygenix Therapeutics, Inc., entered into a strategic collaboration for development and manufacture of EPX-100. Under the agreement, Laurus Synthesis will provide chemistry development services and manufacturing in support of an upcoming clinical trial for EPX-100 for adolescents suffering from Dravet syndrome. In 2017, Takeda Pharmaceutical Company Limited entered into a global collaboration agreement with Ovid for development and commercialization of TAK-935/OV935 for the treatment of developmental and epileptic encephalopathies.
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Dravet Syndrome Treatment Market Regional Analysis
North America is expected to a hold dominant position in the global Dravet syndrome treatment market, owing to increasing initiatives and funding by various organizations to support the development of new treatment for Dravet syndrome. For instances, in 2017, The Dravet Syndrome Foundation—a U.S.-based non-profit organization dedicated to funding the highest caliber research on Dravet syndrome—funded a total amount of US$ 3,600,000 for the development of novel treatment methods for Dravet syndrome. In 2011, Dravet Syndrome Foundation granted an undisclosed amount to U.S.-based OPKO Health, Inc., to support the company’s efforts to develop potential therapeutic agents for the treatment of Dravet syndrome. The market in Europe is expected to exhibit significant growth in the Dravet syndrome treatment market, owing to increasing research and development activities being adopted by key players present in the region. For instance, GW Pharmaceuticals, a British biopharmaceutical company, developed Epidiolex (cannabidiol) based on an ingredient derived from marijuana. The company submitted new drug application (NDA) to the U.S. FDA for Epidiolex, in December 2017. If approved by the FDA, Epidiolex is expected to enter the market in the U.S. by mid of 2018.
Dravet Syndrome Treatment Market Restraint
According to a study published in NCBI in 2015, the dravet syndrome affects only around 1 out of 15,700 individuals in the U.S. The prevalence of dravet syndrome is so rare that most of the population do not have much knowledge about it which is the major factor restraining the dravet syndrome market growth.
Dravet Syndrome Treatment Market Key Players
Key players operating in the Dravet syndrome treatment market include Epygenix Therapeutics, Inc., Ovid Therapeutics, GW Pharmaceuticals Plc., Takeda Pharmaceutical Company Ltd, Zogenix, Inc, OPKO Health Inc., Biocodex S.A., Biscayne Neurotherapeutics, Inc., and PTC Therapeutics, Inc. Key players in the market are focusing on receiving approval for their novel drugs, from major regulatory bodies such as FDA and European Commission. For instance, in 2017, Biscayne Neurotherapeutics, Inc., received an Orphan Drug designation from the U.S. FDA for its compound BIS-001 indicated for the treatment of Dravet syndrome.
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