Alembic Pharmaceuticals (Alembic) today announced that the Company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg, and 1,600 mcg.
Source:- Alembic Pharmaceuticals
According to Thelansis research, the total prevalent cases of Pulmo-nary Arterial Hypertension (PAH) in 8 major markets ranges from 115,557 in 2019 to 151,495 in 2030 which makes it rare indication. Idiopathic PAH is the most commonly found form of Pulmo-nary Arterial Hypertension (PAH).
Comprehensive insight on patient segmentation based on the type and subtype-specific (Idiopathic PAH, Drug/Toxin Induced, Disease-associated PAH, heritable PAH), PAH associated conditions (Connective Tissue Disease, HIV-related PAH, Portopulmonary Hypertension, and Congenital Heart Disease), Stage (Mild, Moderate and Severe )has been provided into the epidemiology (Incidence and Prevalence) section of the PAH and its treatment in the 8 MM countries, covering the United States, EU5 (Germany, Spain, France, Italy, UK), Japan, and China
The PAH market landscape is pretty crowded with multiple therapies approved and many more in the pipeline, The therapies majorly fall under three categories of mechanisms which are Endothelin Receptor Antagonists (ERAs), Prostacyclin Analogs (PCs), and Nitrous Oxide Stimulants (NO). The NO pathway further includes medications working on the inhibition of PDE5 or soluble guanylate cyclase (sGC) stimulators. Several big pharma is also aiming at the market such as Novartis which is developing an inhaled prostacyclin QCC374. PAH market is also populated by several treprostinil formulations which are largely provided by United Therapeutics. Some new entrants are also coming up with their treprostinil formulations such as Liquidia’s LIQ -861 which is an inhaled dry powder formulation of treprostinil.
Thelansis is specialized in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area which includes both rare / ultra-rare and mainstream indication. Over the period of time, we have built a strong repository of 6,000+ Bio-pharma reports which essentially covers Epidemiology study and Market forecasting based on the KOL opinions. Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the major focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making.
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