Ambrisentan
Encyclopedia
Ambrisentan is a drug indicated for use in the treatment of pulmonary hypertension
.
It functions as an endothelin receptor antagonist
, and is selective for the type A endothelin receptor
(ETA).
Ambrisentan was approved for sale by the U.S. Food and Drug Administration
(FDA) on June 15, 2007 for the once-daily treatment of pulmonary arterial hypertension
.
It was later approved by the European Medicines Agency
for use in the EU on April 2008.
Ambrisentan had previously been designated an orphan drug
by both the FDA and the European Commission, in August 2004 and May 2005 respectively.
patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.
LEAP works by:
Pulmonary hypertension
In medicine, pulmonary hypertension is an increase in blood pressure in the pulmonary artery, pulmonary vein, or pulmonary capillaries, together known as the lung vasculature, leading to shortness of breath, dizziness, fainting, and other symptoms, all of which are exacerbated by exertion...
.
It functions as an endothelin receptor antagonist
Endothelin receptor antagonist
A endothelin receptor antagonist is a drug that blocks endothelin receptors.Three main kinds of ERAs exist:* selective ETA receptor antagonists , which affect endothelin A receptors....
, and is selective for the type A endothelin receptor
Endothelin receptor
There are at least three known endothelin receptors, ETA, ETB1 and ETB2, all of which are G protein-coupled receptors whose activation result in elevation of intracellular-free calcium.-Clinical significance:...
(ETA).
Ambrisentan was approved for sale by the U.S. Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) on June 15, 2007 for the once-daily treatment of pulmonary arterial hypertension
Pulmonary hypertension
In medicine, pulmonary hypertension is an increase in blood pressure in the pulmonary artery, pulmonary vein, or pulmonary capillaries, together known as the lung vasculature, leading to shortness of breath, dizziness, fainting, and other symptoms, all of which are exacerbated by exertion...
.
It was later approved by the European Medicines Agency
European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
for use in the EU on April 2008.
Ambrisentan had previously been designated an orphan drug
Orphan drug
An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease...
by both the FDA and the European Commission, in August 2004 and May 2005 respectively.
Clinical uses
Ambrisentan is indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) inpatients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.
The LETAIRIS Education and Access Program
The LETAIRIS Education and Access Program (LEAP) is a program to help physicians and patients learn about the risks of LETAIRIS, including the serious risks of liver injury and birth defects.LEAP works by:
- Providing information to prescribers on the risks of LETAIRIS
- Providing comprehensive education to patients and assistance with obtaining LETAIRIS
- Requiring enrollment of both prescriber and patient in LEAP
- Controlling dispensing through a specialized distribution network (specialty pharmacies)