The Arena Pharmaceuticals drug APD811 has been granted orphan drug designation by the FDA
Arena Pharmaceutical’s, a biopharmaceutical company with a focus on developing drugs to address unmet medical needs, has been granted an orphan designation for their experimental pulmonary arterial hypertension drug, APD811.
The company is well known for its drug BELVIQ, which is used for weight management in obese patients who are afflicted with another comorbid condition such as type 2 diabetes or hypertension.
This FDA orphan drug designation gives Arena a number of benefits with regards to the development of the drug. It will give Arena tax breaks and incentives during the clinical trial stages of development, and if the drug receives marketing approval, it will be granted a 7 year marketing exclusivity period.
The drug will be advanced to phase II clinical trials by the end of the year. The drug is orally administered and is an agonist (activator) of the prostacyclin receptor. The activation of this receptor is associated with vasodilation (the widening of blood vessels), which can potentially treat many different types of vasospastic diseases which involve the constriction of blood vessels.
Read more about it here: Arena Pharmaceuticals’ APD811 Granted Orphan Drug Status for Pulmonary Arterial Hypertension