DTMT Network

Alembic Pharmaceuticals has received tentative approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application for Selexipag Tablets, a recent announcement from the company said.

The company informed that Selexipag Tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce the risk of hospitalisation for PAH and have an estimated annual market size of 461 million US dollars.

Selexipag have been granted orphan drug status for PAH by the USFDA in December 2015 while it was approved in Europe in May 2016.

PAH is a rare disease, with an estimated prevalence ranging from 10 to 52 cases per million and is caused when the tiny arteries in the lungs narrow resulting in blocking the blood flow through the lungs resulting in an increase in the blood pressure in the lungs.