Zydus Gets USFDA Orphan Drug Status for Desidustat to Treat Sickle Cell Disease

Zydus Lifesciences has received Orphan Drug Designation (ODD) from the US Food and Drug Administration for Desidustat, an oral drug being developed to treat sickle cell disease (SCD).

The orphan status is given to medicines aimed at treating rare diseases affecting fewer than 200,000 people in the United States and helps support their development.

About Desidustat

Desidustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
It has the potential to increase haemoglobin levels and red blood cell counts, which may help patients suffering from sickle cell disease.

Limited Treatment Options for Sickle Cell Disease

Current treatments for SCD remain limited.

• Hydroxyurea can reduce painful crises but is not effective for all patients and may cause side effects.
• Blood transfusions are costly, not always available, and carry medical risks.

A Phase II clinical study of Desidustat has already been completed, and the results are expected to be published in a medical journal.

Benefits of Orphan Drug Status

The USFDA designation provides several development incentives, including:

• Tax credits for clinical testing
• Waiver of certain regulatory fees
• Potential seven-year marketing exclusivity in the US after approval

Management Commentary

Zydus Managing Director Dr. Sharvil Patel said the designation highlights the urgent need for new treatments for sickle cell disease and expressed confidence that Desidustat could help address this unmet medical need.

About Zydus Lifesciences

Zydus Lifesciences is a global research-driven healthcare company that develops, manufactures, and markets a wide range of therapies.
The company employs over 29,000 people worldwide, including around 1,500 R&D scientists.

Also Read: REC Dividend Record Date on February 06: Interim Dividend of ₹4.60!

Zydus Lifesciences Share Price Movement

Zydus Lifesciences share price (NSE: ZYDUSLIFE) was trading at around ₹887.30, down ₹17.70 or 1.96% on February 6 at about 12:56 PM. The stock opened at ₹905 and touched an intraday high of ₹905 and a low of ₹884. Over the past year, the stock has recorded a 52-week high of ₹1,059.05 and a 52-week low of ₹795. Zydus Lifesciences currently offers a dividend yield of about 1.24%, with a quarterly dividend amount of ₹2.75 per share.

Conclusion

The USFDA’s orphan drug status for Desidustat marks an important step for Zydus in developing a new treatment for sickle cell disease. If approved, the drug could offer meaningful benefits to patients while strengthening the company’s innovation pipeline.

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