Zydus Lifesciences’ Desidustat Gets Orphan Designation

Zydus Lifesciences announced on Friday that the U.S. health regulator has granted Orphan Drug Designation to Desidustat, a new oral medication for treating Sickle Cell Disease.

The U.S. Food and Drug Administration (USFDA) gives orphan drug status to medicines that are being developed for rare diseases affecting fewer than 200,000 people in the United States. This designation helps companies by providing incentives, such as faster approval processes, tax benefits, and market exclusivity, to encourage the development of treatments for rare conditions.

Desidustat, developed by Zydus Lifesciences, is designed to help patients with Sickle Cell Disease, a genetic disorder that affects red blood cells and can cause severe pain, organ damage, and other complications.

With the Orphan Drug Designation, Zydus can now accelerate the development and testing of Desidustat in the U.S., bringing hope to patients suffering from this rare and serious disease.

This recognition by the USFDA also highlights Zydus Lifesciences’ commitment to innovation and its focus on addressing unmet medical needs in rare diseases.