GlaxoSmithKline PLC ViiV Healthcare receives complete response letter (7379X)
23 Dicembre 2019 - 8:01AM
UK Regulatory
TIDMGSK
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
Kathleen Quinn
+1 202 603 5003
Analyst/Investor enquiries: Sarah Elton-Farr +44 (0) 20 8047 5194
Danielle Smith +44 (0) 20 8047 0932
James Dodwell +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 rns@lseg.com or visit www.rns.com.
END
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