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Menarini Group's drug elastrant has been granted priority review status by the FDA

 Last Update: 2022-08-20
 Source: Internet
 Author: User

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Florence, Italy and New York, Aug.

MENARINI_GROUP

FDA's Priority Review designation grants drugs that it believes may provide significant improvements in safety and efficacy compared to standard of care (SOC) in the treatment, diagnosis or prevention of serious diseases

Elcin Barker Ergun, CEO of Menarini Group, said: "The FDA's acceptance of our NDA application and granting of Priority Review status is an important regulatory milestone for our company

Data from the EMERALD Phase 3 study provided support for the NDA application

Elastrant is an investigational compound that has not yet been approved by any regulatory agency

The Menarini Group received a global license to elastran in July 2020 from Radius Health, Inc (NASDAQ: RDUS), which conducted and successfully completed the EMERALD study

About the Phase 3 study of elasitran (RAD1901) and EMERALD

Elastrant is an investigational selective estrogen receptor degrader (SERD) currently being evaluated as a once-daily oral treatment for patients with ER+/HER2- advanced or metastatic breast cancer

Source: Menarini Industrie Farmaceutiche Riunite

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