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news.The US Food and Drug Administration (FDA) has granted orphan drug status for Arena Pharmaceuticals' APD811, an orally available agonist of the prostacyclin (IP) receptor to treat pulmonary arterial hypertension (PAH).
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APD811 is an investigational drug candidate internally discovered and developed by Arena for the treatment of vasospastic diseases, such as PAH.
Arena Operations Global Regulatory Affairs senior vice-president and head Craig Audet said the FDA Office of Orphan Products Development (OOPD) evaluates scientific and clinical data submissions from sponsors to identify and designate drug candidates that could potentially treat rare diseases to help advance the evaluation and development of such products.
"We are pleased with the OOPD’s designation of orphan drug status for the active moiety of APD811, and we look forward to advancing this drug candidate into a Phase II clinical trial program later this year," Audet said.
PAH is characterized by increased pressure in the arteries that carry blood from the heart to the lungs.
The increased pressure strains the heart, which can limit physical activity, resulting in heart failure.
There is an estimated five-year survival rate of 57% from diagnosis, according to the data from the Registry to EValuate Early And Long-term PAH disease management (REVEAL) of patients in the US.