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US Food and Drug Administration Issues Complete Response Letter Regarding the Tracleer Supplemental New Drug Application

- Completion and Approval of Risk Evaluation and Mitigation System (REMS) submission required for final FDA review for inclusion of less severe PAH patients in the product label

ALLSCHWIL/BASEL, SWITZERLAND - 02 March 2009 - Actelion Ltd (SIX: ATLN) announced today it has received a complete response letter from the US Food and Drug Administration (FDA) regarding the supplemental New Drug Application (NDA) the company filed in August 2007.

In this supplemental NDA, Actelion asked that the US product indication be expanded to include patients suffering from Pulmonary Arterial Hypertension (WHO Group I) with less severe disease (WHO Class II - IV symptoms). Since November 2001, Tracleer® has been commercially available in the United States for PAH patients with WHO III-IV symptoms.

In its Complete Response letter, the FDA has informed Actelion that the REMS submission (Risk Evaluation and Mitigation Strategy) Actelion submitted in September 2008 needs to be finalized and approved before the FDA will then, in turn, be able to conclude the review of the supplemental Tracleer® NDA expanding the indication to the less severe PAH patient population.

Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion, commented: "We will continue to diligently work with the US Food and Drug Administration on the ongoing REMS submission in order to expand the US product label to include less severe PAH patients."

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Notes to the editor:

About Pulmonary Arterial Hypertension (PAH) Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. The function of the heart and lungs is severely compromised, manifested by a limited exercise capacity, and, ultimately, a reduced life expectancy. Approximately 100,000 people in Europe and the United States are afflicted with either primary or secondary forms of the disease related to conditions or tissue disorders that affect the lungs, such as scleroderma, lupus, HIV/AIDS or congenital heart disease.

PAH is associated with structural changes in both the pulmonary vasculature and the right ventricle. Recent advances [1] in the understanding of the pathogenic factors leading to the pulmonary vascular disease have led to the development of new therapies targeting specific pathways (the prostacyclin pathway; the endothelin pathway; and the nitric oxide pathway) [2]. The available therapies have positive effects in PAH, but they do not provide a cure, and in many patients the disease will progress. PAH remains a serious life-threatening condition [2,3]. Early recognition and an understanding of the selection and timing of therapeutic options remain critical elements in the optimal management of patients with this disorder.

About Tracleer® in Pulmonary Arterial Hypertension (PAH) Tracleer® (bosentan), the first oral dual endothelin receptor antagonist, is approved for the treatment of pulmonary arterial hypertension (PAH) and made available by Actelion subsidiaries in the United States, the European Union, Japan, Australia, Canada, Switzerland and other markets worldwide.

Requires attention to two significant safety concerns: Potential for serious liver injury (including rare cases of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring) - Liver monitoring of all patients is essential prior to initiation of treatment and monthly thereafter. Tracleer® treatment must not be initiated in women of childbearing potential unless they practice reliable contraception and participate in monthly pregnancy testing. Due to these risks, Tracleer® is only supplied through a controlled distribution.

References:

1. Farber HW; Loscalzo J. Mechanisms of disease: pulmonary arterial hypertension. N. Eng. J. Med. 2004; 351:1655-65. 2. Humbert M; Sitbon O; Simonneau G. Treatment of pulmonary arterial hypertension. N. Eng. J. Med. 2004;351:1425-36. 3. Humbert M; Morrell NW; Archer SL; et al. Cellular and molecular pathobiology of pulmonary arterial hypertension. J. Am. Coll. Cardiol. 2004; 43: Suppl. 12: 13S-24S. 4. Tracleer® SPC.

Actelion Ltd Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, 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 key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream. Actelion's over 1900 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI® )

For further information please contact: Roland Haefeli Vice President, Head of Investor Relations & Public Affairs Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil +41 61 565 62 62 +1 650 624 69 36 http://www.actelion.com<http://www.actelion.com/>

Press Release PDF<http://hugin.info/131801/R/1294162/293463.pdf>

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Posted: March 2009

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