Orphan drug designation for Tolera's diabetes drug

KALAMAZOO, Mich. The Food and Drug Administration has granted orphan drug designation to an investigational treatment for diabetes.

Tolera Therapeutics said Tuesday that the FDA had given the designation to TOL101, a monoclonal antibody for treating recent onset immune-mediated Type 1 diabetes. The drug is designed for patients aged 16 years and younger.

The FDA gives orphan drug designation to treatments for diseases and conditions that affect fewer than 200,000 people annually in the United States; though an orphan drug still is subject to the same regulatory scrutiny as any drug, the designation waives government filing fees and provides tax credits related to development costs and other support.

“We are pleased with this designation,” Tolera CEO John Puisis said. “Clinicians and patients need an effective and safe means to modulate the immune system, particularly for juvenile diabetes patients.”