Final FDA decision anticipated by 24 January 2022; if
approved, cabotegravir would be the first long-acting therapy for
HIV PrEP
ViiV Healthcare, the global specialist HIV company majority
owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi
as shareholders, today announced that the U.S. Food and Drug
Administration (FDA) has accepted and granted Priority Review for a
New Drug Application (NDA) for investigational, injectable
cabotegravir long-acting for pre-exposure prophylaxis, or PrEP. The
Priority Review designation of cabotegravir long-acting for PrEP
builds upon its prior identification as a Breakthrough Therapy by
the FDA.
If approved, cabotegravir would be the first, long-acting
therapy for the prevention of HIV for individuals at risk of
sexually acquired HIV-1 infection, who have a negative HIV-1 test
prior to initiation. The FDA has set a target approval date of 24
January 2022.
The NDA was based on the results from two phase IIb/III studies,
HPTN 083 and HPTN 084, which evaluated the safety and efficacy of
cabotegravir long-acting for PrEP in men who have sex with men,
transgender women, and cisgender women.1,2 The blinded, randomised
portions of both studies were stopped early by independent Data
Safety Monitoring Boards after cabotegravir was shown to be
superior to daily oral emtricitabine/tenofovir disoproxil fumarate
(FTC/TDF) tablets in preventing the acquisition of HIV.1,2
Kimberly Smith, M.D., MPH, Head of Research & Development
at ViiV Healthcare, said: “The FDA’s Priority Review
designation of cabotegravir long-acting for PrEP underscores the
importance of this medicine, supported by the results of the HPTN
studies, which demonstrated cabotegravir’s superior efficacy over
daily oral FTC/TDF tablets. In the United States, fewer than 25% of
those who could benefit from PrEP are currently taking it, which
points to the need for additional HIV prevention options. We
believe new options like investigational cabotegravir long-acting
for PrEP will help play a significant role in our collective
efforts to end the HIV epidemic.”
ViiV Healthcare will initiate submissions of cabotegravir
long-acting for PrEP to other regulatory authorities by the end of
2021. Cabotegravir long-acting for PrEP has not been approved or
licensed anywhere in the world for use in HIV prevention.
About HPTN 083 (NCT02720094) The HPTN 083 study is a
phase IIb/III double blind study designed to evaluate the safety
and efficacy of long-acting injectable cabotegravir for HIV
prevention administered every eight weeks compared to daily oral
FTC/TDF tablets (200 mg/300 mg). The trial design included an oral
lead-in phase to assess tolerability to cabotegravir before
administering the intramuscular injection. HPTN 083 was conducted
in 4,566 men who have sex with men and transgender women who have
sex with men. The study opened to enrolment in November 2016 at
research centres in Argentina, Brazil, Peru, United States, South
Africa, Thailand and Vietnam.1
Long-acting cabotegravir was found to be superior to daily oral
FTC/TDF in preventing HIV acquisition in the study population. The
most common adverse reactions (all grades) observed in at least 1%
of subjects receiving long-acting cabotegravir were injection site
reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders,
nausea, dizziness, flatulence, and abdominal pain. For further
information on HPTN 083 please see
https://clinicaltrials.gov/ct2/show/NCT02720094.
About HPTN 084 (NCT03164564) The HPTN 084 study is a
phase IIb/III double blind study designed to evaluate the safety
and efficacy of long-acting injectable cabotegravir for HIV
prevention administered every eight weeks compared to daily oral
FTC/TDF tablets (200 mg/300 mg) in 3,223 cisgender women who are at
increased risk of HIV acquisition. The trial design included an
oral lead-in phase to assess tolerability to cabotegravir before
administering the intramuscular injection. HPTN 084 opened to
enrolment in November 2017 and is being conducted at research
centres in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda
and Zimbabwe.2
Long-acting cabotegravir was found to be superior to daily oral
FTC/TDF in preventing HIV acquisition in the study population. The
most common adverse reactions (all grades) observed in at least 1%
of subjects receiving long-acting cabotegravir were injection site
reactions, diarrhea, headache, fatigue, sleep disorders, nausea,
dizziness, abdominal pain, vomiting, myalgia, and rash. For further
information please see
https://clinicaltrials.gov/ct2/show/NCT03164564.
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 as a shareholder in October 2012. The company’s
aims are 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/about-us/.
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 in the Company's
Annual Report on Form 20-F for 2020, GSK's Q2 Results and any
impacts of the COVID-19 pandemic.
Registered in England &
Wales:
GSK PLC
ViiV Healthcare Limited
No. 3888792
No. 06876960
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
References 1 Marzinke M, Grinsztejn B, Fogel J,
Piwowar-Manning EM et al, Laboratory Analysis of HIV Infections in
HPTN 083: Injectable CAB for PrEP. Conference on Retroviruses and
Opportunistic Infections Abstract 153 2 Delany-Moretlwe S,
Hughes JP et al. Long acting injectable cabotegravir is safe and
effective in preventing HIV infection in cisgender women. HIV
Research for Prevention Virtual Conference (HIVR4P 2021) abstract
HY01.02, 2021. 3 DC statement on FDA approval of drug for
HIV prevention. News release CDC NCHHSTP Newsroom. July 16, 2012.
Accessed September 7, 2021.
https://www.cdc.gov/nchhstp/newsroom/2012/fda-approvesdrugstatement.html
4 Centers for Disease Control and Prevention. Prevent new
HIV transmissions by using proven interventions, including
pre-exposure prophylaxis (PrEP) and syringe services programs
(SSPs). Accessed September 7, 2021.
https://www.cdc.gov/endhiv/prevent.html
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