Linzagolix (Yselty®) – Uterine Fibroids

Milestones

MAA Filed Nov2020

NDA: Q3:21

PRIMROSE 1:

Positive 24W primary endpoint results (July2020)

Sustained efficacy and continued safety confirmed at 52W (Dec2020)

76W (6 months post treatment) results expected Q2:21

PRIMROSE 2:

Positive 24W primary endpoint results (Dec2019)

Sustained efficacy and continued safety confirmed at 52W (Jul2020)

Continued pain reduction and evidence of bone mineral density (BMD) recovery at 76W (6 months post treatment) (Dec2020)

Clinical Trials

Recruitment Completed

Commercial Rights

Exclusive Worldwide (ex Asia)

Condition

Uterine fibroids

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Note that the following information contains information on investigational medicinal products. These products have not yet been approved for marketing by the European Medicines Agency or the U.S. Food and Drug Administration and are still under development. Further additional investigations may be needed in order for the marketing authorization to be granted, which grant may depend on a variety of factors and is not guaranteed. Click on “return” if you do not wish to receive such information. By clicking on “continue” you acknowledge that you wish to receive scientific information on our investigational products.

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Disclaimer

Note that the following information contains information on investigational medicinal products. These products have not yet been approved for marketing by the European Medicines Agency or the U.S. Food and Drug Administration and are still under development. Further additional investigations may be needed in order for the marketing authorization to be granted, which grant may depend on a variety of factors and is not guaranteed. Click on “return” if you do not wish to receive such information. By clicking on “continue” you acknowledge that you wish to receive scientific information on our investigational products.

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