FDA Fast-Tracks Drug for SSc-ILD

The U.S. Food and Drug Administration (FDA) on September 13 granted a fast-track designation to efzofitimod for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Efzofitimod is a first-in-class immunomodulator that downregulates innate and adaptive immune responses in uncontrolled inflammatory disease. A Phase 1b/2a study among patients with pulmonary sarcoidosis, a major form of ILD, recently established proof of concept, according to a news release from the developer, aTyr Pharma.

Previously, the FDA had granted orphan drug status to efzofitimod for SSc.

The company is sponsoring a Phase 3 clinical trial to further determine the drug’s effectiveness and safety profile for pulmonary sarcoidosis.

—Priyam Vora

Reference:
aTyr Pharma Receives FDA Fast Track Designation for Efzofitimod for Treatment of Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD). News Release. Globe Newswire; September 13, 2022. [Press Release]