GlaxoSmithKline's New Drug Application For Zejula Accepted By US FDA

(Alliance News) - Brentford-based pharmaceutical giant GlaxoSmithKline PLC said Monday the US ...

Alliance News 24 February, 2020 | 3:42PM
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(Alliance News) - Brentford-based pharmaceutical giant GlaxoSmithKline PLC said Monday the US Food & Drug Administration has accepted its submission of a supplemental new drug application for Zejula.

The application is for the use of Zejula, also known as niraparib, as a maintenance treatment in women with advanced ovarian cancer which responded to platinum-based chemotherapy regardless of biomarker status.

The new drug application was based on results from the PRIMA study, which demonstrated clinically-meaningful outcomes from Zejula treatment.

Zejula is already approved in the US as a maintenance treatment for women with recurrent ovarian cancer who are in response to platinum-based chemotherapy regardless of BRCA mutation status.

Shares in Glaxo were down 1.2% at 1,628.20 pence on Monday in London.

By Dayo Laniyan; dayolaniyan@alliancenews.com

Copyright 2020 Alliance News Limited. All Rights Reserved.

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Securities Mentioned in Article

Security Name Price Change (%) Morningstar
Rating
GlaxoSmithKline PLC 1,520.20 GBX -0.04

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