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GlaxoSmithKline PLC - ViiV Healthcare receives complete response letter

RNS Number : 7379X
GlaxoSmithKline PLC
23 December 2019
 

Issued: 21 December 2019, London UK - LSE Announcement

 

ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV

 

London, 21 December 2019 - ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults.  

 

The reasons given in the CRL relate to Chemistry Manufacturing and Controls (CMC). There have been no reported safety issues related to CMC and there is no change to the safety profile of the products used in clinical trials to date.  ViiV Healthcare will work closely with the FDA to determine the appropriate next steps for this New Drug Application.  

 

Cabotegravir is an integrase strand transfer inhibitor developed by ViiV Healthcare and rilpivirine is a non-nucleoside reverse transcriptase inhibitor developed by Janssen Sciences Ireland UC. The cabotegravir and rilpivirine long-acting regimen is an investigational product and not approved anywhere in the world.

 

 

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

 

For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.

 

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com.

 

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2018.

 

ViiV Healthcare Media enquiries:

Audrey Abernathy

+1 919 605 4521

 

Stephen Rea

 

+44 78 8126 9009

 

 

 

GSK Global Media enquiries:

Simon Steel

+44 (0) 20 8047 5502

 

 

Analyst/Investor enquiries:

Kathleen Quinn

 

Sarah Elton-Farr

+1 202 603 5003

 

+44 (0) 20 8047 5194

 

Danielle Smith

James Dodwell

+44 (0) 20 8047 0932

+44 (0) 20 8047 2406

 

Jeff McLaughlin

+1 215 751 7002

 

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The person responsible for arranging the release of this announcement on behalf of GSK is V.A. Whyte, Company Secretary.

 


This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact [email protected] or visit www.rns.com.
 
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