Drug Overview
In 1995, GlaxoSmithKline’s Flolan (epoprostenol) became the first therapy to be specifically approved for the orphan disease of pulmonary arterial hypertension (PAH). As a prostaglandin analog, the drug acts as a potent vasodilator and platelet aggregation inhibitor through binding of the prostaglandin I2 (PGI2) receptor. In PAH, the production of PGI2 is chronically impaired and this plays a crucial role in the excessive vasoconstriction, pulmonary vasculature remodeling, and thrombosis formation associated with the disease pathology.
Analyst Outlook
Despite demonstrating a significant improvement in survival, Flolan (epoprostenol; GlaxoSmithKline) usage is limited by the drug’s unfavorable administration (Barst et al., 1996). As such, the drug is the leading therapy for patients with the highest disease burden. The drug’s high price point has also negatively impacted on uptake, but increasing generic competition should help to improve access to treatment.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Flolan : Pulmonary arterial hypertension
LIST OF FIGURES
12 Figure 1: Flolan – SWOT analysis for pulmonary arterial hypertension
13 Figure 2: Datamonitor Healthcare’s drug assessment summary for Flolan in pulmonary arterial
hypertension
13 Figure 3: Datamonitor Healthcare’s drug assessment summary for Flolan in pulmonary arterial
hypertension
LIST OF TABLES
4 Table 1: Flolan – drug profile
7 Table 2: Pivotal clinical trial data for Flolan in pulmonary arterial hypertension
9 Table 3: Registry studies showing Flolan’s improvement on survival in pulmonary arterial
hypertension