Corbus Pharmaceuticals Receives FDA Orphan Drug Designation for Lenabasum for the Treatment of Dermatomyositis

Corbus Pharmaceuticals (NASDAQ:CRBP) has announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lenabasum drug for the treatment of dermatomyositis (DM).

As quoted in the press release:

The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose or prevent diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees.

About Dermatomyositis

Dermatomyositis is a rare and serious systemic autoimmune condition characterized by skin and muscle involvement. Like other autoimmune diseases, it affects more women than men and morbidity is more severe in black, Asian and Native American populations. The disease is characterized by distinct skin lesions that can be accompanied by erosions, photosensitivity, itch, ulcers, calcinosis and hair loss as well as other abnormalities. Muscle inflammation and atrophy is a characteristic of the disease and can manifest as weakness. Dermatomyositis affects as many as 80,000 people in the US, EU and Japan. Mortality is high with 5-year survival of 70% and 10-year survival of 57%. Standard of care includes antimalarial drugs and potent immunosuppressive agents, which often lead to significant adverse effects.

Click here to read the full press release.