Martin Pharmaceuticals’ Linvantra Receives FDA Orphan Drug Designation in Second Indication

Martin Pharmaceuticals, a clinical stage pharmaceutical company focused on repurposing already-approved drugs to offer life-changing advances to patients afflicted with rare (orphan) diseases or challenging medical conditions, has been granted Orphan Drug Designation by the FDA for Livantra in the treatment of Pulmonary Arterial Hypertension. Earlier this year Livantra received orphan drug designation for the treatment of Acute-on-Chronic Liver Failure (ACLF).

The FDA’s Orphan Drug Designation program is intended to encourage the development of drugs and biologics that may provide benefit to patients suffering from rare diseases or conditions, specifically those affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as tax credits for clinical research costs.

Pulmonary Arterial Hypertension (PAH) is a progressive, life-threatening disorder. It occurs when the very small arteries throughout the lungs narrow, thereby increasing the resistance to blood flow through the lungs. In an effort to compensate, blood pressure intensifies in the pulmonary artery. Ultimately, the increased blood pressure can damage the right ventricle of the heart, making it difficult for the heart to pump blood through the lungs to be oxygenated.

It’s estimated that somewhere between 35,000 to 60,000 people in the U.S. are living with PAH. Current therapies aim to reduce symptoms and improve quality of life. Despite improvements in patient management, mortality rates for PAH remain high. The National Institutes of Health Registry has reported a three-year mortality rate of approximately 50 percent.

(Source: Martin Pharmaceuticals)