The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act, 1940 and Rules, 1945.
On December 07, 2017, CDSCO approved Macitentan Bulk/Tablets 10 mg, which is indicated for the treatment of Pulmonary Arterial Hypertension (PAH, World Health Organization (WHO) group I) to delay disease progression1. The manufacture and marketing approval for Macitentan Tablet was granted to MSN laboratories Private Limited. The Subject Expert Committee (SEC) of Cardiovascular & Renal, CDSCO, after detailed deliberation has recommended grant of manufacturing and marketing permission with local clinical trial (Phase IV) waiver and submission of Bioequivalence (BE) study data.
The committee also observed that -
- PAH is a rare disease and not many therapeutic options are available at present.
- The drug has shown a significant 45% reduction in composite of first morbidity and mortality.
- The drug is approved as orphan drug by United States Food & Drug Administration (USFDA) and Europe, the Middle East and Africa (EMEA)2.
Macitentan is a nonselective inhibitor of endothelin-1 receptors (both type A and B). Inhibition of endothelin receptors disrupts the intracellular pathways that leads to vasoconstriction, thus causing vasodilation. Because macitentan has high affinity for pulmonary endothelin receptors, it preferentially causes vasodilation in the pulmonary vasculature, thereby decreasing pulmonary vascular pressure. The current indications are for symptomatic pulmonary arterial hypertension, classified as WHO group 1 (idiopathic). Macitentan has been associated with a low rate of serum enzyme elevations during therapy, but has yet to be implicated in cases of clinically apparent acute liver injury.3 Macitentan was first approved by the United States Food and Drug Administration (FDA) on December 18, 2013 for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression4.
About Pulmonary Arterial Hypertension (PAH)
Pulmonary hypertension (PH) is a severe, rare lung disease characterized by high blood pressure in the pulmonary arteries. Due to the condition, the pulmonary arteries, which are responsible for transporting the blood from the right heart ventricle to the lungs, become narrowed and thickened. In order to properly pump the blood, the heart needs to work harder, which can lead to enlargement and weakening of the organ, as well as potential right heart failure.
Pulmonary Arterial Hypertension (PAH, WHO Group I) is a subtype of Pulmonary Hypertension (PH) associated with abnormalities in the arterioles, when the causes of the disease are not known. The PH including inherited pulmonary hypertension, as well as pulmonary hypertension caused by connective tissue diseases that affect the body's structure or composition of the tissue like congenital heart problems, high blood pressure in liver (portal hypertension), HIV, thyroid gland disorder, sickle cell disease, glycogen storage disorders, and rare blood conditions like pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis5.
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