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Arena Pharmaceuticals' APD811 Granted Orphan Drug Status for Pulmonary Arterial Hypertension

3.1 from 11 votes
Wednesday, September 03, 2014

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced that the US Food and Drug Administration (FDA) has granted orphan drug status to APD811 for the treatment of pulmonary arterial hypertension.

"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," said Craig M. Audet, Ph.D., Arena's Senior Vice President, Operations & Head of Global Regulatory Affairs. "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 2 clinical trial program later this year."

About Orphan Drug Status

Under the Orphan Drug Act, the FDA may grant orphan drug designation to drug candidates intended to treat a rare disease or condition that generally affects fewer than 200,000 individuals in the United States. Orphan drug designation qualifies the sponsor of the drug candidate for various development incentives, which may include tax credits for qualified clinical testing, an exemption from fees under the Prescription Drug User Fee Act (PDUFA), and a seven-year marketing exclusivity period following approval. Orphan drug status applies specifically to the active moiety and the indication for which it is granted, and is not applicable to other indications for that moiety.

About Pulmonary Arterial Hypertension (PAH)

PAH is a progressive, life-threatening disorder 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, result in heart failure and reduce life expectancy. Based on data from the Registry to EValuate Early And Long-term PAH disease management (REVEAL) of patients in the United States, there is an estimated five-year survival rate of 57% from diagnosis.

About APD811

APD811, an orally available agonist of the prostacyclin (IP) receptor, is an investigational drug candidate internally discovered and developed by Arena and intended for the treatment of vasospastic diseases, such as PAH.

About Arena Pharmaceuticals

Arena is embracing the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena's internally discovered drug, BELVIQ® (lorcaserin HCl), is approved in the United States, and Arena is focused on discovering, developing and commercializing additional drugs to address unmet medical needs. Arena's US operations are located in San Diego, California, and its operations outside of the United States, including its commercial manufacturing facility, are located in Zofingen, Switzerland. For more information, visit Arena's website at

Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ® is a registered trademark of Arena Pharmaceuticals GmbH.



Arena Pharmaceuticals, Inc.

Media Contact: Russo Partners

Operations & Head of Global Regulatory Affairs  

Craig M. Audet, Ph.D., Senior Vice President

Tel: 858.453.7200, ext. 1612 

David Schull, President

Tel: 858.717.2310


Source: Arena Pharmaceuticals
3.1 from 11 votes
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