REG - GSK PLC - Apretude for PrEP receives EMA approval

GSKAnnouncement

19/09/2023 07:00

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RNS Number : 8329M  GSK PLC  19 September 2023

Issued: 19 September 2023, London UK

 

European Commission authorises ViiV Healthcare's Apretude (cabotegravir
long-acting and tablets) for HIV prevention

 

·   Given as few as six times per year, cabotegravir has demonstrated
superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing
the risk of HIV acquisition in clinical trials. 1  (#_edn1) (, 2  (#_edn2)
, 3  (#_edn3) , 4  (#_edn4) )

·   With approximately 100,000 people newly diagnosed with HIV each year in
Europe, 5  (#_edn5) expanding HIV prevention options is crucial in reducing
HIV transmission.

 

 

 

GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist
HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders,
today announced that the European Commission has authorised Apretude
(cabotegravir long-acting (LA) injectable and tablets) for HIV prevention.
Cabotegravir is indicated in combination with safer sex practices for
pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1
infection in high-risk adults and adolescents (at least 12 years of age),
weighing at least 35 kg.

 

Cabotegravir LA injectable and tablets for PrEP is the first and only HIV
prevention option approved in the European Union (EU) that reduces the number
of doses needed for effective HIV prevention from 365 daily pills to as few as
six injections per year. Cabotegravir LA injectable and tablets for PrEP has
demonstrated superior efficacy to daily oral emtricitabine/tenofovir
disoproxil fumarate (FTC/TDF) in reducing the risk of HIV acquisition in
clinical trials, giving people in the EU more options for
PrEP.(1)(,)(2)(,)(3)(,)(4)

 

Deborah Waterhouse, CEO at ViiV Healthcare, said: "This authorisation marks a
pivotal milestone for people across the EU who could benefit from an
innovative, long-acting HIV prevention option that may better suit their
personal preferences. Long-acting PrEP, alongside other HIV prevention
strategies, plays an important role in helping to address some of the
challenges that people may have with oral PrEP options".

 

This approval is 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 LA for PrEP
in HIV-negative men who have sex with men (MSM), transgender women and
cisgender women who were at increased risk of sexually acquired HIV. The
studies demonstrated that cabotegravir LA for PrEP was superior to daily oral
FTC/TDF tablets, with clinical trial participants given cabotegravir LA for
PrEP experiencing a 69% lower rate of HIV acquisition compared to FTC/TDF
tablets in HPTN 083 (12 vs 39; annual incidence: 0.37% vs 1.22%; HR 0.31 [CI:
0.16, 0.58]), and a 90% lower rate of HIV acquisition compared to FTC/TDF
tablets in HPTN 084 (3 vs 36; annual incidence: 0.15% vs 1.85%; HR 0.10 [CI:
0.04, 0.27]).(1)(,)(2)(,)(3)(,)(4)

 

Cabotegravir LA for PrEP is approved for use in the US, Australia, South
Africa, as well as other countries as Apretude. Submission to other regulatory
agencies is on-going.

 

About cabotegravir extended-release injectable suspension

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. 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 are at increased risk of HIV acquisition. 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.

 

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.

 

The Apretude EMA Reference Information, including a full list of adverse
events and the complete important safety information in the EU, will shortly
be available on the European Medicines Agency website.

 

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 could
benefit from HIV prevention options. 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 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.

 

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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 'Risk factors" in the company's Annual Report on Form 20-F for 2022,
and Q2 Results for 2023 and any impacts of the COVID-19 pandemic.

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References

 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. Cabotegravir for
the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised
clinical trial. The Lancet 2022;399(10337):1779-1789. DOI:
10.1016/S0140-6736(22)00538-4

 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. Last accessed August 2023.

 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. Last accessed August 2023.

 5  (#_ednref5) 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.
Last accessed March 2023. Last accessed August 2023.

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