FDA Advisory Committee Unanimously Recommends OVATION Pharmaceuticals, Inc.'s Sabril(R) (vigabatrin) for the Treatment of Two Catastrophic Epilepsies
January 9, 2009
DEERFIELD, Ill.--(BUSINESS WIRE)--OVATION Pharmaceuticals, Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) voted unanimously (23-0) to recommend Sabril® (vigabatrin) as a monotherapy for Infantile Spasms (IS). This vote comes after yesterday's unanimous (24-0) recommendation of Sabril as an adjunctive treatment for adults with refractory Complex Partial Seizures (CPS) who have inadequately responded to several anti-epileptic drugs (AEDs) and for whom the potential benefits outweigh the potential risks of therapy. The advisors also recommended that the drug be available under a Risk Evaluation and Mitigation Strategy (REMS). If approved, Sabril would be the first and only drug approved in the United States for the treatment of IS. The FDA is not required to, but usually follows the recommendations of the Advisory Committee.
"We are very pleased with the Advisory Committee's unanimous recommendation in support of the safety and efficacy of Sabril for the treatment of adults with refractory CPS and infants with IS," said Jeffrey S. Aronin, OVATION President and Chief Executive Officer. "This is a significant milestone for patients and their caregivers who have been waiting so long for an effective and approved treatment option for these catastrophic epilepsies. OVATION's late-stage central nervous system pipeline demonstrates our steadfast commitment to developing therapies that serve the unmet medical needs of patients, particularly where no treatment options exist or where current treatments are inadequate."
Complex Partial Seizures that occur in more than one-third of all epilepsies are seizures that originate from a single region of the brain and cause impaired consciousness. Despite the availability of more than 20 AEDs, approximately 30 to 36 percent of adults with CPS suffer from seizures that are unresponsive, or refractory, to treatment. Patients with uncontrolled seizures have a nearly 40 times higher risk of mortality than patients whose seizures are adequately controlled.
An estimated 8,500 infants in the U.S. have been diagnosed with IS, a devastating epilepsy syndrome that usually strikes infants between three to six months old. Spasms can occur in clusters of up to 100 spasms at a time and have a detrimental effect on neurological development. As many as 20 percent of infants affected die before age five. An estimated 2,500 new cases of IS are reported each year.
A special risk management program is being developed by OVATION to ensure that Sabril is understood and used properly. The program, available through SHARE (Support, Help and Resources for Epilepsy), will not only address important elements of the Sabril REMS, but will also provide important educational tools and information to help support physicians, patients and their families as they monitor and manage severe and hard-to-treat epilepsies.
About Sabril (vigabatrin)
Sabril is an oral anti-epileptic drug being developed in the United States for the treatment of adults with refractory CPS and infants with IS. It is believed to work by inhibiting the enzyme responsible for metabolizing gamma-aminobuytric acid transaminase (GABA-T). Because epileptic seizures are thought to result from low levels of GABA in the brain, by decreasing GABA-T, which allows the build up of GABA in the synapses, Sabril may reduce the likelihood of seizures.
Sabril is a U.S. registered trademark of OVATION.
Important Safety Information
Sabril (vigabatrin) may induce a distinctive permanent peripheral visual field defect (pVFD) in some patients. Central vision and visual acuity are unaffected. In a long-term multinational study in patients with partial epilepsy, the prevalence of a confirmed Sabril-induced pVFD was approximately 25 percent of adult patients and 15 percent of children receiving long-term therapy. In a long-term study of infants and children with Infantile Spasms (IS), using the most sensitive parameter (30 Hz flicker amplitude), the prevalence of a sustained Sabril-induced retinal abnormality was approximately 31 percent. The risk for pVFD increases with total dose and duration of use and the defect is irreversible once it occurs. Appropriate visual testing is needed for detection.
The concomitant use of Sabril with retinotoxic drugs is contraindicated. The estimated suicidality and sudden death (SUDEP) rates in patients receiving Sabril was similar to that observed in other anti-epilepsy drugs (AEDs). Abnormal MRI signal changes have been reported in some infants with IS receiving Sabril. Sabril doses should be tapered gradually to avoid withdrawal seizures.
In controlled and uncontrolled clinical trials of Sabril in patients with epilepsy including those with CPS, the most common (=10%) adverse events (AEs) reported for Sabril-treated patients were: headache, fatigue, somnolence, dizziness, convulsion, weight increased, and nasopharyngitis.
In controlled clinical trials of Sabril in patients with IS, the most common (=5%) AEs reported for Sabril-treated patients were: upper respiratory tract infection, otitis media, pyrexia, viral infection, irritability, somnolence, sedation, vomiting, constipation, pneumonia, diarrhea, insomnia, ear infection, rash, nasal congestion, decreased appetite, sinusitis, bronchitis, lethargy, and convulsion.
About OVATION Pharmaceuticals
OVATION is a fast growing biopharmaceutical company that develops and commercializes medically necessary therapies to satisfy unmet medical needs for patients with severe illnesses. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients' lives through its focus on central nervous system (CNS), hematology/oncology, and hospital-based therapies. The three new launches the company expects over the next three years will be fueled largely by its late-stage CNS pipeline, which is one of the most robust in the industry. OVATION has been recognized for excellence in the global pharmaceutical and biotechnology industries with the 2006 and 2007 "Pharma Company of the Year" award from Scrip magazine for small to mid-sized enterprises. More information about the company, its products and full prescribing information may be found at www.ovationpharma.com.
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