REG - GSK PLC - NMPA approves Vocabria+Rekambys in China

GSKAnnouncement

26/10/2023 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20231026:nRSZ3259Ra&default-theme=true

RNS Number : 3259R  GSK PLC  26 October 2023

26 October 2023, London UK

 

ViiV Healthcare receives approval from China's National Medical Products
Administration (NMPA) for Vocabria (cabotegravir) used in combination with
Rekambys (rilpivirine), the first and only complete long-acting HIV-1
injectable treatment

 

·   The marketing authorisation for rilpivirine long-acting injection was
received on the 18 October 2023

·   The complete long-acting regimen enables people living with HIV in
China, who are virologically suppressed to reduce the treatment dosing days
from 365 to 12 or 6 per year after initiation.

·   With an estimated 1.045 million people living with HIV in China, 1 
expanding treatment options is critical to reduce the scale of the epidemic in
the country.

 

 

 

GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist
HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders
announced that the National Medical Products Administration (NMPA) of China
has approved ViiV Healthcare's Vocabria (cabotegravir injection) used in
combination with the Janssen Pharmaceutical Companies of Johnson &
Johnson's Rekambys (rilpivirine long-acting injection) for the treatment of
HIV-1 infection. Prior to the recent marketing authorisation for rilpivirine
long-acting injection, cabotegravir injection and tablets were approved in
China in July 2023.

 

Cabotegravir injection is indicated in combination with rilpivirine
long-acting injection for the treatment of human immunodeficiency virus type-1
(HIV-1) infection in adults who are virologically suppressed, on a stable
antiretroviral (ARV) regimen without present or past evidence of viral
resistance to, and no prior virological failure with, agents of the
non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor
(INI) classes. Vocabria (cabotegravir) tablets are approved for use in
combination with rilpivirine tablets (trade name Edurant) as an optional oral
lead-in before initiating injections or as oral therapy for those who will
miss planned injection doses.

 

By the end of October 2020, there were an estimated 1.045 million people
living with HIV in China.1 Advancements in treatment mean many people living
with HIV can now live long and healthy lives, however, some may still struggle
with daily oral HIV medication. It may act as a constant reminder of HIV, be a
cause of fear that their HIV status will be accidently disclosed or create
challenges with adherence.

 

Deborah Waterhouse, CEO of ViiV Healthcare, said: "At ViiV Healthcare, we are
proud to be able to offer innovative solutions that meet the evolving needs of
people living with HIV. The approval of cabotegravir injection and rilpivirine
long-acting injection marks a step forward in helping to change the treatment
experience for some people living with HIV in China who may have challenges
with daily HIV therapies. We look forward to working closely with our partners
in China to make this treatment available to those who could benefit from a
long-acting regimen, part of our commitment to ensuring no person living with
HIV is left behind."

 

This approval is based on data from three pivotal trials: the ATLAS
(Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First
Long-Acting Injectable Regimen) studies, and the phase IIIb ATLAS-2M study,
which collectively included more than 1,200 participants from 16 countries.
ATLAS and FLAIR demonstrated the efficacy and safety of cabotegravir and
rilpivirine compared to standard-of-care oral regimens, while ATLAS-2M showed
that once every two month dosing had comparable efficacy to once monthly.(( 2 
(#_edn2) ))(,( 3  (#_edn3) )),( 4  (#_edn4) )  In ATLAS, 92.5% of
participants receiving long-acting therapy and 95.5% of those receiving oral
therapy remained virally suppressed at week 48 (adjusted difference: -0.3%;
95% confidence interval  CI : -6.7% to 0.7%), meeting the criterion for
non-inferiority.(2) In FLAIR, 93.6% of participants receiving long-acting
therapy and 93.3% of participants receiving oral therapy remained virally
suppressed at week 48 (adjusted difference: 0.4%; 95% CI: −3.7% to 4.5%),
meeting the criterion for non-inferiority.(3) In the pooled analysis of ATLAS
and FLAIR most long-acting recipients (83%) experienced injection site
reactions, which decreased in incidence over time. Injection site reactions
led to the withdrawal of 6 (1%) participants. The serious adverse event rate
was 4% in each arm.(( 5  (#_edn5) )) In ATLAS-2M, cabotegravir plus
rilpivirine long-acting every eight weeks was non-inferior to dosing every
four weeks (adjusted difference: 0.8%; 95% CI: -0.6% to 2.2%) after 48 weeks
of treatment. The safety profile was similar between dosing groups, with 844
(81%) of 1,045 participants having adverse events (excluding injection site
reactions); no treatment-related deaths occurred.4

 

ViiV Healthcare's mission is to leave no person living with HIV behind. As the
only pharmaceutical company solely focused on HIV and AIDS, ViiV Healthcare is
working to deliver a broad range of treatments that meet the needs of a wide
variety of people living with HIV. The long-acting regimen approved on the 18
October 2023 was developed in collaboration between ViiV Healthcare and
Janssen. This builds on ViiV Healthcare's industry-leading portfolio which is
centred on delivering innovative medicines for the HIV community.

 

About cabotegravir

Cabotegravir is an integrase strand transfer inhibitor (INSTI) developed by
ViiV Healthcare for the treatment of HIV-1 in virologically suppressed adults.
It is approved as a long-acting formulation for use in combination with a
rilpivirine long-acting formulation in the US, the EU and in other countries.

 

INSTIs, like cabotegravir, 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 infection.

 

About rilpivirine and rilpivirine long-acting

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that
works by interfering with an enzyme called reverse transcriptase, which in
turn stops the virus from multiplying. It is approved as Edurant, an oral
formulation, for the treatment of HIV-1 infection in combination with other
antiretroviral agents in antiretroviral treatment-naïve patients 12 years of
age and older and weighing at least 35kg with a viral load ≤100,000 HIV RNA
copies/mL. It is also approved as Rekambys, a long-acting formulation that is
indicated, in combination with cabotegravir injection, for the treatment of
human immunodeficiency virus type 1 (HIV-1) infection in adults who are
virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable
antiretroviral regimen without present or past evidence of viral resistance
to, and no prior virological failure with, agents of the NNRTI and INI class.

 

Administration and dosing of cabotegravir and rilpivirine

Cabotegravir injection used in combination with rilpivirine injection is a
complete long-acting regimen dosed once monthly or once every two months for
the treatment of HIV-1 in adults who are virologically suppressed (HIV-1 RNA
<50 copies/mL) on a stable antiretroviral (ARV) regimen without present or
past evidence of viral resistance to, and no prior virological failure with,
agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and
integrase inhibitor (INI) classes. Cabotegravir and rilpivirine should be
administered intramuscularly (IM) at two separate, gluteal injection sites by
a healthcare professional at the same appointment. Prior to the initiation of
the injections, cabotegravir and rilpivirine oral tablets can be taken as oral
lead-in for approximately one month (at least 28 days) to assess tolerability
to the medicines.

 

For once-monthly dosing, each person will receive a loading dose that includes
one 600 mg injection of cabotegravir and one 900 mg injection of rilpivirine
administered intramuscularly in the gluteal site. Then, each month after that,
each person will receive one 400 mg injection of cabotegravir and one 600 mg
injection of rilpivirine.

 

For once every two months dosing, each person will receive a loading dose that
includes one 600 mg injection of cabotegravir and one 900 mg injection of
rilpivirine, which is repeated one month later. Then, every two months after
that, each person will receive one 600 mg injection of cabotegravir and one
900 mg injection of rilpivirine as a continuation dose.

 

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 acquiring 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 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.

 

 ViiV Healthcare enquiries
 Media:                     Nicola Andre      +44 (0) 7901 887073  (London)
                            Rachel Jaikaran   +44 (0) 7823 523755  (London)
                            Audrey Abernathy  +1 919 605 4521      (North Carolina)

 

 GSK enquiries
 Media:               Tim Foley          +44 (0) 20 8047 5502  (London)
                      Sarah Clements     +44 (0) 20 8047 5502  (London)
                      Kathleen Quinn     +1 202 603 5003       (Washington DC)
                      Lyndsay Meyer      +1 202 302 4595       (Washington DC)
                      Alison Hunt        +1 540 742 3391       (Washington DC)

 Investor Relations:  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)
                      Camilla Campbell   +44 (0) 7803 050238   (London)
                      Steph Mountifield  +44 (0) 7796 707505   (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 under
Item 3.D 'Risk factors" in the company's Annual Report on Form 20-F for 2022,
and Q2 Results for 2023.

Registered in England & Wales:

No. 3888792

 

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

 

References

 1  (#_ednref1) Jun-Jie X, Meng-Jie H, Yong-Jun J, et al. Prevention and
control of HIV/AIDS in China: lessons from the past three decades. Chinese
Medical Journal 2021; 134(23):2799-2809.

 2  (#_ednref2) Swindells S, Andrade-Villanueva J-F, Richmond G, et al.
Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression.
New England Journal of Medicine 2020; 382:1112-1123.

 3  (#_ednref3) Orkin C, Arasteh K, Hernandez-Mora MG, et al. Long-acting
cabotegravir and rilpivirine after oral induction for HIV-1 infection. New
England Journal of Medicine 2020; 382:1124-1135.

 4  (#_ednref4) Overton ET, Richmond G, Rizzardini G, et al. Long-acting
cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1
infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label,
phase 3b, non-inferiority study. The Lancet 2020; 396(10267):1994-2005.

 5  (#_ednref5) Rizzardini G, Overton ET, Orkin C, et al. Long-Acting
Injectable Cabotegravir + Rilpivirine for HIV Maintenance Therapy: Week 48
Pooled Analysis of Phase 3 ATLAS and FLAIR Trials. J Acquir Immune Defic Syndr
2020; 1;85(4):498-506.

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 (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCGZMZGMKZGFZZ