FDA grants marketing approval for Lundbeck's Sabril® (vigabatrin)
(Thomson Reuters ONE) - - First FDA-approved treatment for infantile spasms- New adjunctive treatment for adults with refractory complexpartial seizuresH. Lundbeck A/S today announced that the US Food and DrugAdministration (FDA) has granted two New Drug Application (NDA)approvals for Sabril® (vigabatrin) Tablets and Oral Solution.Lundbeck Inc. plans to launch Sabril in the US during the thirdquarter of 2009, with an extensive Risk Evaluation and MitigationStrategy (REMS) program as required by the FDA and created incollaboration with the agency.Sabril is the first therapy approved by the FDA for the treatment ofinfantile spasms (IS) and an important new adjunctive therapeuticoption for the approximately 30 to 36 percent of adults with complexpartial seizures (CPS) whose seizures remain uncontrolled in spite ofhaving many antiepileptic therapies already available[i] [ii].Sabril is indicated as monotherapy for paediatric patients one monthto two years of age with IS for whom the potential benefits outweighthe potential risk of vision loss. IS is characterized by spasms thatmay occur in clusters of up to 100 at a time. Sabril represents theonly treatment approved by the FDA to help manage thisdifficult-to-treat condition.Sabril is also indicated as adjunctive therapy for adult patientswith refractory CPS who have inadequately responded to severalalternative treatments and for whom the potential benefits outweighthe risk of vision loss. Sabril is not indicated as a first-lineagent for CPS. This patient group is inherently difficult to treatand is in need of additional treatment alternatives to help reducethe number of seizures.Commenting on the approval of the lead compound in its CNS pipeline,Ulf Wiinberg, President and CEO at Lundbeck said, "Infantile spasmsand refractory complex partial seizures in adults aredifficult-to-treat epilepsies and we are pleased to be able toaddress the unmet medical need patients with infantile spasms havefaced and to offer an additional choice in treating refractorycomplex partial seizures. FDA approval of Sabril is an important stepforward for the entire epilepsy community and provides patients witha new treatment option that could reduce seizures among these adultpatients and may eliminate spasms in a certain proportion of childrenwith infantile spasms."Lundbeck has together with the FDA established a comprehensive REMSto manage the risk of permanent vision loss associated with theproduct. The Sabril REMS, which was a critical component in receivingFDA approval, specifies elements, such as restricted productdistribution, required vision testing and mandatory risk-benefitassessments, to manage the risk of vision loss associated withSabril. Like all other antiepileptic drugs, the REMS also addressesthe risk for suicidality associated with the class.The Sabril REMS is administered through Lundbeck's SHARE (Support,Help and Resources for Epilepsy) program, a comprehensive patient andphysician support program designed to provide tools and resources forall of Lundbeck's epilepsy products, including Sabril. Through SHAREand the recently established SHARE Call Center, patients, caregiversand physicians will have access to information and tools to helpmanage severe and uncontrolled epilepsy, programs to help facilitateinitial and ongoing use of Sabril and support from a team dedicatedto helping people fully understand and navigate the Sabrilprescribing process.Sabril causes permanent vision loss in infants, children and adults.Sabril-induced vision loss includes progressive and permanentbilateral concentric visual field constriction in 30 percent or moreof patients on the therapy that ranges in severity from mild tosevere, including tunnel vision to within 10 degrees of visualfixation, and can result in disability. There are also some reportsthat Sabril can damage the central retina and decrease visual acuity.The onset is unpredictable and can occur within weeks of startingtreatment, or sooner, or at anytime during treatment even aftermonths or years.Financial guidanceThe content of this release will have no influence on the LundbeckGroup's financial result for 2009.Lundbeck made an upfront payment of USD 600 million (or approximatelyDKK 3.5 billion) immediately upon closing of the acquisition ofOvation Pharmaceuticals, Inc. An additional payment of USD 300million (or approximately DKK 1.6 billion) will now be paid inconnection with the approval of Sabril by the FDA.About complex partial seizuresThere are three million Americans affected by epilepsy[iii] andapproximately 35 percent have CPS, the single largest seizure type,which originates from a single region of the brain and can causeimpaired consciousness[iv]. Despite the availability of more than 20antiepileptic drugs, approximately 30 to 36 percent of adults withCPS continue to have uncontrolled seizures[v]. Sabril provides a newand valuable adjunctive treatment option for adult CPS patients whohave not responded to several alternative treatments and areconsidered 'refractory' to treatment. Given the potential benefitcompared to the risk of permanent vision loss, it is expected thatonly a small percentage of refractory CPS patients will initiate andmaintain treatment with Sabril as adjunctive therapy.About infantile spasmsInfantile spasms is a difficult-to-treat epilepsy syndrome thatusually strikes infants between three to six months old[vi]. Anestimated 8,500 infants in the US have been diagnosed with IS[vii].Each year, approximately 2,500 new cases of IS are reported in the USand until now, no FDA-approved treatments have been available. Sabrilmay not be appropriate for use in all IS patients given the potentialrisk of permanent vision loss.About Sabril® (vigabatrin) Tablets and Oral SolutionSabril is an oral antiepileptic drug developed in the US by LundbeckInc. Sabril is available in two formulations - in 500 mg tablets foruse as adjunctive therapy for adults with refractory CPS and in 500mg packets of powder for oral solution for infants with IS. Theprecise mechanism of Sabril's anti-seizure effect is unknown, but isbelieved to be the result of its action as an irreversible inhibitorof gamma-aminobutyric acid transaminase (GABA-T), the enzymeresponsible for the metabolism of the inhibitory neurotransmitterGABA. This action results in increased levels of GABA in the centralnervous system. No direct correlation between plasma concentrationand efficacy has been established. The duration of drug effect ispresumed to be dependent on the rate of enzyme resynthesis ratherthan on the rate of elimination of the drug from the systemiccirculation[viii].Lundbeck contactsInvestors: Media:Jacob Tolstrup Mads KronborgDirector, IR & Communication Media Relations+45 36 43 30 79 +45 36 43 28 51Palle Holm Olesen Kasper RiisHead of Investor Relations Media Relations+45 36 43 24 26 +45 36 43 28 33Magnus Thorstholm JensenInvestor Relations Officer+45 36 43 38 16About LundbeckH. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an internationalpharmaceutical company highly committed to improve the quality oflife for people suffering from central nervous system (CNS)disorders. For this purpose Lundbeck is engaged in the research anddevelopment, production, marketing and sale of pharmaceuticals acrossthe world, targeted at disorders like depression and anxiety,schizophrenia, insomnia, Huntington's, Alzheimer's and Parkinson'sdiseases.Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark,and employs today over 5,500 people worldwide. Lundbeck is one of theworld's leading pharmaceutical companies working with CNS disorders.In 2008, the company's revenue was DKK 11.3 billion (approximatelyEUR 1.5 billion or USD 2.2 billion). For more information, pleasevisit www.lundbeck.com.[i] Kwan P, Brodie MJ. Early identification of refractory epilepsy.New England Journal of Medicine. February 3, 2000;342:314-319.[ii] Devinsky O. Patients with refractory seizures. New EnglandJournal of Medicine. May 20, 1999; 340:1565-70.[iii] Epilepsy and Seizure Statistics. Epilepsy Foundation.org.http://www.epilepsyfoundation.org/about/statistics.cfm. Last accessed03/09/2009.[iv] Murro, Anthony M. EMedicine.com. Complex Partial Seizures.http://www.emedicine.com/Neuro/topic74.htm Last accessed onFebruary 17, 2009.[v] Sperling, M. The consequences of uncontrolled epilepsy. CNSSpectr 2004;9(2):98-101,106-109.[vi] National Institute of Neurological Disorders and Stroke. NINDSInfantile Spasms Information Page. Available at:http://www.ninds.nih.gov/disorders/infantilespasms/infantilespasms.htm?css=print.Last accessed on December 8, 2008.[vii] Hurst D. The epidemiology of infantile spasms. In: Dulac O,Chugani H. Dalla Bernardina B., eds. Infantile Spasms and WestSyndrome. Philadelphia, PA: Saunders; 1994.[viii] Sabril® (vigabatrin) for Oral Solution full PrescribingInformation, including Boxed Warninghttp://hugin.info/130085/R/1336518/318103.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 21.08.2009 - 19:31 Uhr
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