REG - GSK PLC - EMA validates MAA for cabotegravir LA for PrEP

GSKAnnouncement

28/10/2022 07:01

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RNS Number : 4236E  GSK PLC  28 October 2022

European Medicines Agency validates ViiV Healthcare's marketing authorisation
application for cabotegravir long-acting injectable for HIV Prevention

·    The marketing application is based on results from the HPTN 083 and
084 phase IIb/III studies in which the injectable medicine, given as few as
six times per year, demonstrated superior efficacy to a daily oral PrEP option
(FTC/TDF tablets) in reducing the risk of HIV acquisition 1  (#_edn1) (, 2 
(#_edn2) , 3  (#_edn3) , 4  (#_edn4) )

 

 

London, 28 October 2022 - ViiV Healthcare, the global specialist HIV company
majority owned by GSK, with Pfizer and Shionogi as shareholders, today
announced that the European Medicines Agency (EMA) has validated the company's
marketing authorisation application (MAA) seeking approval of cabotegravir
long-acting injectable for pre-exposure prophylaxis (PrEP) to reduce the risk
of sexually acquired HIV-1. Cabotegravir long-acting for HIV prevention is
administered six times per year, after initiation. 5  (#_edn5)

 

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV
Healthcare, said: "With approximately 100,000 people in Europe newly diagnosed
with HIV each year, this submission is an important step forward in offering
expanded options for HIV prevention.(6) Long-acting prevention options, if
used appropriately and at scale, could have the potential to transform the
shape of the HIV epidemic and we look forward to continuing to work with
community groups, governments and regulatory authorities to make this option
available for those who need it."

 

Submission to the EMA was supported by data from two international phase
IIb/III multicentre, randomised, double-blind, active controlled studies, HPTN
083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir
long-acting for PrEP in HIV-negative men who have sex with men, transgender
women, and cisgender women who were at increased risk of HIV. The studies
demonstrated that cabotegravir long-acting for PrEP was superior to daily oral
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), with clinical trial
participants experiencing a 69% lower rate of HIV acquisition compared to
FTC/TDF tablets in HPTN 083, and a 90% lower rate of HIV acquisition compared
to FTC/TDF tablets in HPTN 084. (1,2,3,4)

 

Cabotegravir long-acting for PrEP is currently approved in the US, Australia
and Zimbabwe as Apretude.

About cabotegravir extended-release injectable suspension(5)

Cabotegravir long-acting for HIV prevention is the first and only long-acting
injectable PrEP option proven superior to daily oral FTC/TDF in reducing HIV
acquisition.

Cabotegravir long-acting for PrEP is an integrase strand transfer inhibitor
(INSTI). INSTIs, like cabotegravir extended-release injectable suspension,
inhibit HIV replication by preventing the viral DNA from integrating into the
genetic material of human immune cells (T-cells). This step is essential in
the HIV replication cycle and is also responsible for establishing chronic
disease.

 

Cabotegravir long-acting for PrEP is provided as an injection administered six
times per year and is initiated with a single 600 mg (3-ml) injection given
one month apart for two consecutive months. After the second initiation
injection, the recommended continuation injection dose is a single 600 mg
(3-ml) injection given every two months. Vocabria (cabotegravir oral tablets)
may be administered for approximately one month before initiating the first
injection to assess the tolerability of the medicine.

 

About HPTN 083 (NCT02720094)(1,3)

The HPTN 083 trial is a phase IIb/III double blind non-inferiority trial
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 included the
prespecified ability to test for superiority of long-acting cabotegravir over
FTC/TDF.

The trial design included an oral lead-in phase to assess tolerability to
cabotegravir before administering the intramuscular (IM) injection. Each
participant was to receive a maximum of three years of blinded trial
medication. The trial opened to enrolment in November 2016. HPTN 083 was
conducted in 4,566 HIV-negative men who have sex with men and transgender
women who have sex with men, who had evidence of behaviour that would put them
at high-risk for sexually acquiring HIV-1. The trial is being conducted at
research centres in Argentina, Brazil, Peru, the United States, South Africa,
Thailand, and Vietnam.

Long-acting cabotegravir was found to be superior to daily oral FTC/TDF in
preventing HIV acquisition in the trial population. The most common adverse
reactions (all grades) observed in at least 1% of subjects receiving
long-acting cabotegravir were injection site reactions, diarrhoea, 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
(https://clinicaltrials.gov/ct2/show/NCT02720094) .

 

About HPTN 084 (NCT03164564)(2,4)

The HPTN 084 trial is a phase III double blind superiority trial designed to
evaluate the safety and efficacy of the long-acting injectable cabotegravir
for HIV prevention administered every eight weeks compared to daily oral
FTC/TDF tablets (200 mg/300 mg) in 3,224 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 IM 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.

 

Long-acting cabotegravir was found to be superior to daily oral FTC/TDF in
preventing HIV acquisition in the trial population. The most common adverse
reactions (all grades) observed in at least 1% of subjects receiving
long-acting cabotegravir were injection site reactions, diarrhoea, headache,
fatigue, sleep disorders, nausea, dizziness, abdominal pain, vomiting,
myalgia, and rash.

 

For further information please see
https://clinicaltrials.gov/ct2/show/NCT03164564
(https://clinicaltrials.gov/ct2/show/NCT03164564) .

 

Please see full U.S. Prescribing Information
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF)
for
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF)
Apretude
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF)
.
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF)

 

Trademarks are owned by or licensed to the ViiV Healthcare group of
companies.

 

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November
2009 by GSK (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 became a ViiV shareholder in
October 2012. The company's aims are to take a deeper and broader interest in
HIV and 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
(http://www.viivhealthcare.com/) .

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at gsk.com/company
(https://www.gsk.com/en-gb/about-us/)

 ViiV Healthcare enquiries:
 Media enquiries:               Catherine Hartley     +44 7909 002 403      (London)
                                Rachel Jaikaran       +44 7823 532 755      (London)

 GSK enquiries:
 Media enquiries:               Tim Foley             +44 (0) 20 8047 5502  (London)
                                Dan Smith             +44 (0) 20 8047 5502  (London)
                                Kathleen Quinn        +1 202 603 5003       (Washington DC)
                                Lyndsay Meyer         +1 202 302 4595       (Washington DC)

 Analyst/Investor enquiries:
                                Nick Stone            +44 (0) 7717 618834   (London)
                                James Dodwell         +44 (0) 20 8047 2406  (London)
                                Mick Readey           +44 (0) 7990 339653   (London)
                                Josh Williams         +44 (0) 7385 415719   (London)
                                Jeff McLaughlin       +1 215 751 7002       (Philadelphia)
                                Frannie DeFranco      +1 215 751 4855       (Philadelphia)

 
 

 

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 2021, GSK's Q2 Results for 2022
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

 1  (#_ednref1) Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for
HIV Prevention in Cisgender Men and Transgender Women. The New England Journal
of Medicine 2021;385:595-608. DOI: 10.1056/NEJMoa2101016

 2  (#_ednref2) Delaney-Moretlwe S, Hughes J, Bock P, et al. Long acting
injectable cabotegravir is safe and effective in preventing HIV infection in
cisgender women: interim results from HPTN 084. Presented at HIV R4P 2021.

 3  (#_ednref3) Clinical Trials.gov - Safety and Efficacy Study of Injectable
Cabotegravir Compared to Daily Oral Tenofovir Disoproxil
Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in
HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men.
Available at

https://clinicaltrials.gov/ct2/show/NCT02720094
(https://clinicaltrials.gov/ct2/show/NCT02720094) . Last accessed October
2022.

 4  (#_ednref4) Clinical Trials.gov - Evaluating the Safety and Efficacy of
Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for
Pre-Exposure Prophylaxis in HIV-Uninfected Women. Available at
https://clinicaltrials.gov/ct2/show/NCT03164564
(https://clinicaltrials.gov/ct2/show/NCT03164564) . Last accessed October
2022.

 5  (#_ednref5) Apretude Prescribing Information.
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Apretude/pdf/APRETUDE-PI-PIL-IFU.PDF)

(6) ECDC/World Health Organisation (2021) HIV/AIDS surveillance in Europe.
Available at
https://www.ecdc.europa.eu/sites/default/files/documents/2021-Annual_HIV_Report_0.pdf
(https://www.ecdc.europa.eu/sites/default/files/documents/2021-Annual_HIV_Report_0.pdf)
. Last accessed October 2022.

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