Less Ads, More Data, More Tools Register for FREE

US FDA Rejects New Drug Application For ViiV Healthcare HIV Treatment

Sat, 21st Dec 2019 11:40

(Alliance News) - ViiV Healthcare said Saturday it has received a complete response letter from the US Food & Drug Administration related to its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.

The FDA sends a complete response letter if it determines to not approve a new drug application in its current form.

ViiV, a joint venture of GlaxoSmithKline PLC, Pfizer Inc and Shionogi Ltd, said the reasons given by the FDA for its rejection relate to chemistry manufacturing and controls, rather than any safety issues. It said it will work with the US regulator to determine next steps for the application.

By Tom Waite; thomaslwaite@alliancenews.com

Copyright 2019 Alliance News Limited. All Rights Reserved.

Related Shares

More News

LONDON MARKET CLOSE: Stocks Mixed Amid Mute Start To Second Half

LONDON MARKET CLOSE: Stocks Mixed Amid Mute Start To Second Half

1 Jul 20 17:11

Inovio Pharmaceuticals's Covid-19 vaccine triggers immune response

(Sharecast News) - Inovio Pharmaceuticals's experimental vaccine against the novel coronavirus was found to be safe in an early stage clinical trial and successfully induced an immune response in the majority of participants in the test.

30 Jun 20 18:34

Single course of Covid-19 treatment to cost $2,340 per patient - Gilead

(Sharecast News) - Gilead Sciences has announced it will charge developed countries $390 a vial for remdesivir, its antiviral drug currently being investigated for use in Covid-19 patients.

29 Jun 20 12:00

TOP NEWS: GlaxoSmithKline Gets First Approval For Duvroq In Japan

TOP NEWS: GlaxoSmithKline Gets First Approval For Duvroq In Japan

29 Jun 20 09:03

Login to your account

Don't have an account? Click here to register.