"Any promotional activity which is inconsistent with the black box warning may constitute misbranding of a drug product which is a violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 352(f)(1) and (n). On
"Antoniu, Expert Opin Ther Targets 2008
"Knobloch et al, 2010 Annual Congress of the
"Henderson et al, 2010 Annual Congress of the
"Gilead Sciences News Release dated
In addition to obtaining background information on this patent application, NewsRx editors also obtained the inventors' summary information for this patent application: "This section provides a general summary of the invention and is not a comprehensive disclosure of all of its features.
"As described above in the background, there are earlier reports suggesting that a selective ETA antagonist has potential therapeutic utility for the treatment of pulmonary fibrosis. However, it is surprisingly discovered that ambrisentan could cause a greater risk of idiopathic pulmonary fibrosis progression. In an embodiment, therefore, there is provided a method of treating pulmonary hypertension in a patient in need thereof, said method comprising: administering a therapeutically effective amount of ambrisentan to the patient with pulmonary arterial hypertension, wherein the patient has been determined not to have idiopathic pulmonary fibrosis.
"In another embodiment, there is provided a method of treating arterial pulmonary hypertension in a patient in need thereof, comprising: administering a therapeutically effective amount of ambrisentan to the patient with pulmonary arterial hypertension; wherein the patient has been determined not to have idiopathic pulmonary fibrosis, and wherein the method is carried out without drug labeling instruction to monitor one or more biomarkers of liver function during ambrisentan treatment.
"In yet another embodiment, there is provided a method of treating pulmonary arterial hypertension in a patient in need thereof, comprising: diagnosing a patient with pulmonary arterial hypertension; screening the patient for idiopathic pulmonary fibrosis; determining that the patient does not have idiopathic pulmonary fibrosis; and administering a therapeutically effective amount of ambrisentan to the patient with pulmonary arterial hypertension.
BRIEF DESCRIPTION OF THE DRAWINGS
"FIG. 1 shows evaluation of drug-induced serious hepatotoxicity (eDISH) plot comparing maximum bilirubin values to maximum alanine aminotransferase (ALT).
"FIG. 2 shows eDISH plot comparing maximum bilirubin values to maximum aspartate aminotransferase (AST).
"FIG. 3 shows Letairis Education and Access Program (LEAP) patients by exposure duration.
"FIG. 4 shows empiric Bayesian geometric mean (EBGM) scores for ambrisentan and bosentan hepatic events.
"FIG. 5 is a chart showing mean change in 6-minute walk distance in the placebo and ambrisentan groups.
"FIG. 6 is a chart showing time to clinical worsening with Kaplan-Meier estimates of the proportions of failures in ARIES-1 and ARIES-2."
For more information, see this patent application: Gillies,
Keywords for this news article include: Pharmaceutical Companies, Drugs, Pfizer, Bosentan, Letairis, Sulfones, Marketing, Treatment, Hepatology, Advertising, Ambrisentan, Respirology, Legal Issues, Sulfonamides, Therapeutics, Lung Diseases, Liver Function, Aminotransferase, Gastroenterology, Membrane Proteins, Peptide Receptors, Government Agencies.
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