Tracleer receives label extension in the US for the treatment of
patients with mildly symptomatic WH
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Tracleer® indication expansion underscores importance of earlyscreening and treatment to improve outcomesALLSCHWIL, SWITZERLAND - 10 August 2009 - Actelion Ltd (SIX: ATLN)announced today that the U.S. Food and Drug Administration (FDA) hasapproved the company's supplemental New Drug Application (sNDA) forTracleer® (bosentan) to treat patients with mildly symptomatic WHOFunctional Class II (FC II) pulmonary arterial hypertension (PAH).The U.S. FDA has also approved Actelion's Risk Evaluation andMitigation Strategy (REMS) for Tracleer®.Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelioncommented: "Physicians in the United States of America who treat PAHpatients now have access to Tracleer® as an approved therapy forpatients not only in advanced, but also in the early stages of thisrapidly progressing and life-threatening disease. This labelextension is based on EARLY, the only randomized, double blind,placebo controlled study in this mildly symptomatic patientpopulation. The EARLY results demonstrate that Tracleer®significantly reduces risk of clinical worsening in early-stagepatients, thereby slowing down disease progression."Vallerie McLaughlin, MD, Associate Professor of Medicine, Director,Pulmonary Hypertension Program, University of Michigan Health Systemadded: "PAH is a progressive and devastating disease, and patientsare not always treated as early as they should be with therapies thatcan impact disease progression. The approval of Tracleer® for thetreatment of patients with early-stage disease, offers physicians anew, proven therapy that may result in beneficial clinical outcomes."Kirk Taylor, M.D., Senior Vice President, U.S. Medical Group atActelion Pharmaceuticals US, Inc. commented: "The FDA's approval ofTracleer® for use in patients with early-stage PAH provides theopportunity to improve clinical outcomes. Tracleer® is the only PAHmedication that has consistently shown significantly reduced risk ofclinical worsening in PAH patients in three separate Phase IIIstudies."Tracleer® is an oral dual endothelin receptor antagonist approved forthe treatment of PAH FC II, III and IV in the US [1] and for thetreatment of PAH FC II and III in the EU. [2] The company is workingwith authorities on a worldwide basis to expand the label forTracleer® to include patients with FC II PAH.Survey highlights benefits of treating patients with early treatmentResults from a 2008 Harris Interactive survey [3] showed that morethan 90 percent of US physicians who treat pulmonary arterialhypertension (PAH) patients believe that the disease is oftendiagnosed and treated later than it should be.More than three quarters of physicians understand the clinicalbenefits of treating early, and agree that goals of treatment includedelayed time to clinical worsening and improvement across relevanthemodynamic parameters (pulmonary arterial pressure, pulmonaryvascular resistance, cardiac resistance and mean right arterialpressure). However, just over half of these physicians wereprescribing endothelin receptor antagonists (ERAs) at the time of thesurvey.After reviewing the data from the Phase III EARLY study, more than 90percent of physicians polled in the survey agreed that they would belikely to prescribe Tracleer® alone or in combination therapy for FCII PAH patients.The survey polled more than 300 US pulmonologists, cardiologists andrheumatologists who have treated more than five PAH patients in theprevious 12 months. Additional data garnered from the survey is asfollows: * 94 percent of physicians agree that PAH is diagnosed later than it should be * 92 percent of physicians believe PAH is treated later than it should be * 81 percent of physicians agree that early diagnosis and treatment of PAH would provide numerous positive clinical outcomes in this patient population * 51 percent of physicians currently prescribe pharmacologic treatment for early stage FC II patients * 66 percent of physicians would consider prescribing ERAs to FC I/II patientsAbout the pivotal Phase III EARLY studyThe objectives of the prospective, randomized, placebo-controlled,multicenter EARLY (Endothelin Antagonist tRial in miLdlY symptomaticPAH patients) trial were to gain more insights into early stagedisease and to investigate the effects of bosentan specifically inpatients with WHO FC II PAH.The results from EARLY - published in "The Lancet" in June, 2008 [4]- reinforce the relentlessly progressive nature of PAH even in itsearly stages. This was evident from the placebo group deteriorationreflected in the rate of clinical worsening events. The primaryendpoints for the EARLY trial were changes in pulmonary vascularresistance (PVR) and exercise capacity as measured by a six minutewalk test (6-MWD). Disease progression was assessed by the secondaryendpoints, which included time to clinical worsening and WHOFunctional Class.A highly significant reduction of 22.6% in PVR (p <0.0001) and asignificant 77% risk reduction in clinical worsening (p = 0.011) wereseen after 24 weeks of bosentan treatment compared with placebo. Timeto clinical worsening, defined by death, hospitalization for PAH andsymptomatic progression of PAH, showed that more patients remainedstable without signs of deterioration in the bosentan-treated groupcompared with placebo (3.4% vs. 13.2%, p = 0.029). In addition, asignificant delay in WHO functional class deterioration was observedin the bosentan group compared with placebo, providing furtherevidence of delayed disease progression.Although the improvement in 6-MWD did not reach statisticalsignificance (p = 0.076) this may reflect the fact that, on average,enrolled patients had a relatively well preserved exercise capacityat baseline, which can be more difficult to improve. A subgroup ofpatients who received concomitant sildenafil showed improvements inthe bosentan treatment group consistent with the overall results. Thesafety and tolerability profile of bosentan was consistent with thatobserved in previous placebo-controlled clinical trials. ###Notes to the editor:About Pulmonary Arterial Hypertension (PAH)Pulmonary arterial hypertension (PAH) is a chronic, life-threateningdisorder characterized by abnormally high blood pressure in thearteries between the heart and lungs of an affected individual. Thefunction of the heart and lungs is severely compromised, manifestedby a limited exercise capacity, and, ultimately, a reduced lifeexpectancy. Approximately 100,000 people in Europe and the UnitedStates are afflicted with either primary or secondary forms of thedisease related to conditions or tissue disorders that affect thelungs, such as scleroderma, lupus, HIV/AIDS or congenital heartdisease.PAH is associated with structural changes in both the pulmonaryvasculature and the right ventricle. Recent advances [5] in theunderstanding of the pathogenic factors leading to the pulmonaryvascular disease have led to the development of new therapiestargeting specific pathways (the prostacyclin pathway; the endothelinpathway; and the nitric oxide pathway) [6]. The available therapieshave shown positive treatment effects in patients with PAH, but theydo not provide a cure, and in many patients the disease willprogress. PAH remains a serious life-threatening condition [6,7].Early recognition and an understanding of the selection and timing oftherapeutic options remain critical elements in the optimalmanagement of patients with this disorder.About Tracleer® in Pulmonary Arterial Hypertension (PAH)Tracleer® (bosentan), the first oral dual endothelin receptorantagonist, is approved for the treatment of pulmonary arterialhypertension (PAH) and made available by Actelion subsidiaries in theUnited States, the European Union, Japan, Australia, Canada,Switzerland and other markets worldwide.Requires attention to significant safety concerns: Potential forserious liver injury (including rare cases of liver failure andunexplained hepatic cirrhosis in a setting of close monitoring) -Liver monitoring of all patients is essential prior to initiation oftreatment and monthly thereafter. High potential for major birthdefects -Pregnancy must be excluded and prevented by two forms ofbirth control; monthly pregnancy tests should be obtained. Tracleer®is contraindicated for use with cyclosporine A and glyburide. Due tothese risks, in the US, Tracleer® is only supplied through acontrolled distribution.References1. Tracleer® Prescribing Information2. Tracleer® Summary of Product Characteristics3. Online survey conducted by Harris Interactive, May 16-22,2008, among 303 U.S. pulmonologists, cardiologists andrheumatologists who treated at least 5 PAH patients in the previous12 months. Survey was commissioned by Actelion.4. Galiè N, Rubin LJ, Hoeper MM, et al. Treatment of patientswith mildly symptomatic pulmonary arterial hypertension with bosentan(EARLY study): a double-blind, randomised controlled trial. Lancet2008;371:2093-100.5. Farber HW; Loscalzo J. Mechanisms of disease: pulmonaryarterial hypertension. N. Eng. J. Med. 2004; 351:1655-65.6. Humbert M; Sitbon O; Simonneau G. Treatment of pulmonaryarterial hypertension. N. Eng. J. Med. 2004;351:1425-36.7. Humbert M; Morrell NW; Archer SL; et al. Cellular andmolecular pathobiology of pulmonary arterial hypertension. J. Am.Coll. Cardiol. 2004; 43: Suppl. 12: 13S-24S.Actelion LtdActelion Ltd is a biopharmaceutical company with its corporateheadquarters in Allschwil/Basel, Switzerland. Actelion's first drugTracleer®, an orally available dual endothelin receptor antagonist,has been approved as a therapy for pulmonary arterial hypertension.Actelion markets Tracleer® through its own subsidiaries in keymarkets worldwide, including the United States (based in South SanFrancisco), the European Union, Japan, Canada, Australia andSwitzerland. Actelion, founded in late 1997, is a leading player ininnovative science related to the endothelium - the single layer ofcells separating every blood vessel from the blood stream. Actelion'sover 2000 employees focus on the discovery, development and marketingof innovative drugs for significant unmet medical needs. Actelionshares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) aspart of the Swiss blue-chip index SMI (Swiss Market Index SMI®).For further information please contact:Investor ContactRoland HaefeliVice President, Head of Investor Relations & Corporate CommunicationsActelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil+41 61 565 62 62+1 650 624 69 36http://www.actelion.comMedical Media ContactDanielle Bertrand, WeissComm Partners for Actelion+1 415 946 1056dbertrand(at)wcpglobal.comhttp://hugin.info/131801/R/1333588/316171.pdf --- End of Message ---Actelion Pharmaceuticals LtdGewerbestrasse 16 Allschwil SwitzerlandWKN: 936767; ISIN: CH0010532478; Index: SBIOM, SLIFE, SMCI, SMIEXP, SMIM, SPI, SPIEX;Listed: Main Market in SIX Swiss Exchange;
Datum: 10.08.2009 - 07:05 Uhr
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