"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
As a supplement to the background information on this patent application, NewsRx correspondents 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.
"In an embodiment, there is provided a method for treating pulmonary hypertension in a subject, comprising administering to the subject a daily dose of ambrisentan from 1 mg to about 15 mg, wherein the method is carried out without instruction on product labeling to monitor one or more biomarkers of liver function such as liver aminotransferase levels during ambrisentan treatment.
"In another embodiment, there is provided a method for treating pulmonary hypertension in a subject, comprising administering to the subject a daily dose of ambrisentan from 1 mg to about 15 mg, wherein the subject has exhibited a grade 2, 3 or 4 abnormality in one or more biomarkers of liver function, and wherein the method is carried out without instruction on product labeling to monitor one or more biomarkers of liver function such as liver aminotransferase levels during ambrisentan treatment.
"In a particular embodiment, the pulmonary hypertension is PAH which includes idiopathic PAH and non-idiopathic PAH. In various embodiments, the PAH is associated with one or more diseases or conditions such as a congenital heart defect, portal hypertension, use of a drug or toxin other than an anorexigen, thyroid disorder, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathy, myeloproliferative disorder, splenectomy, pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis.
"In yet another embodiment, there is provided a method for treating pulmonary hypertension in a subject where the ambrisentan is administered in combination therapy with a second active agent effective for treatment of the pulmonary hypertension condition or a condition related thereto. In various embodiments, the second active agent comprises at least one drug selected from prostacyclin, prostanoids, phosphodiesterase inhibitors, guanylate cyclase activators, tyrosine kinase inhibitors, calcium channel blockers, diuretics, anticoagulants, oxygen and combinations thereof.
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."
For additional information on this patent application, see: Gillies,
Keywords for this news article include: Pharmaceutical Companies, Drugs, Pfizer, Bosentan, Letairis, Sulfones, Marketing, Treatment, Hepatology, Advertising, Ambrisentan, Legal Issues, Sulfonamides, Liver Function, Aminotransferase, Gastroenterology, Membrane Proteins, Peptide Receptors, Government Agencies, Endothelin Receptors, Offices and Entities.
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