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ViiV Healthcare Announces US FDA Approval of Cabenuva (cabotegravir, rilpivirine) for Virologically Suppressed Adolescents Living With HIV Who Are 12 Years of Age or Older and Weigh at Least 35 kg

The expanded indication for the first and only complete long-acting HIV regimen provides an option with as few as six dosing days per year for virologically suppressed young people living with HIV

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi B.V. as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir, rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.1, 2 The regimen was co-developed as part of a collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson. This approval marks the first time a long-acting HIV treatment is available for the adolescent population, underscoring ViiV Healthcare’s commitment to delivering options for young people living with HIV.

Cabenuva is the first and only complete long-acting HIV treatment regimen and is approved as a once monthly or every-two-months treatment for HIV-1 in virologically suppressed adults and adolescents. Cabenuva contains ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Lynn Baxter, Head of North America at ViiV Healthcare, said: “Adolescents living with HIV and their caregivers face notable treatment challenges with daily oral HIV therapy, including the stress and difficulties of taking medication every day. With today’s approval for Cabenuva, we are bringing this younger population a first-of-its-kind HIV treatment that is dosed as few as six times a year and removes the need for daily oral therapy altogether. At ViiV Healthcare, we are proud to deliver on our mission of leaving no person living with HIV behind and providing an innovative therapy to youth that addresses an unmet need is an important step forward.”

The expanded indication for Cabenuva is supported by studies in adults and by data from the Week 16 interim analysis of the ongoing MOCHA (More Options for Children and Adolescents) study from ViiV Healthcare’s collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT). The efficacy of Cabenuva in adolescents is extrapolated from adults with support from pharmacokinetic analyses showing similar drug exposure. The safety profile in adolescents with the addition of either oral cabotegravir followed by injectable cabotegravir (n = 8) or oral rilpivirine (n = 15) followed by injectable rilpivirine (n = 13) was consistent with the safety profile established with cabotegravir plus rilpivirine in adults.

Based on data from the Week 16 analysis of the MOCHA study in 23 adolescents, adverse reactions were reported in 61% of subjects receiving either cabotegravir or rilpivirine in addition to their current antiretroviral treatment. The majority of these subjects (86%) had a Grade 1 or Grade 2 adverse reaction. The adverse reactions reported by more than one subject (regardless of severity) were injection site pain (n = 13) and insomnia (n = 2). Two subjects had Grade 3 adverse reactions of hypersensitivity (n = 1) and insomnia (n = 1). The Grade 3 adverse reaction of drug hypersensitivity led to discontinuation of rilpivirine during oral lead-in. Sixty-two percent of subjects who received at least one injection of cabotegravir or rilpivirine reported at least one injection site reaction. All injection site reactions were Grade 1 or Grade 2.1

About Cabenuva (cabotegravir, rilpivirine)

Cabenuva is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents who are 12 years of age or older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than <50 copies per /mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen. Rilpivirine is approved in the US as a 25mg tablet taken once a day to treat HIV-1 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 c/ml.

INSTIs 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. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying.

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

About MOCHA/IMPAACT 2017

MOCHA (NCT03497676) is a phase I/II, multi-center, open-label, non-comparative study of oral cabotegravir or rilpivirine and long-acting cabotegravir or rilpivirine in virologically suppressed adolescents living with HIV-1 who are 12 to less than 18 years old. The study is designed to confirm the dose and evaluate the safety, tolerability, acceptability, and pharmacokinetics of cabotegravir and rilpivirine in adolescents living with HIV. Caregivers of adolescent participants in the United States are also enrolled to take part in a single in-depth qualitative interview to contribute to the evaluation of tolerability and acceptability of long-acting therapy, with favorable feedback overall.3 The study is being conducted at research centers in Botswana, South Africa, Thailand, Uganda and the United States.

Important Safety Information for Cabenuva (cabotegravir 200mg/mL; rilpivirine 300mg/mL) extended-release injectable suspensions

Cabenuva is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents who are 12 years of age or older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than <50 copies per /mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions:

Post-Injection Reactions:

Hepatotoxicity:

Depressive Disorders:

Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:

Long-Acting Properties and Potential Associated Risks with Cabenuva:

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Please see full Prescribing Information.

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 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.

About GSK

GSK is a science-led global healthcare company. For further information please visit https://www.gsk.com/en-gb/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 2021 and any impacts of the COVID-19 pandemic.

Registered in England & Wales:

GlaxoSmithKline plc

No. 3888792

ViiV Healthcare Limited

No. 06876960

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

References

  1. Cabenuva (cabotegravir, rilpivirine) Prescribing Information. US Approval March 2022.
  2. Moore CB, Capparelli E, Calabrese K, et al. Safety and PK of Long-Acting Cabotegravir and Rilpivirine in Adolescents. Presented at CROI 2022.
  3. Lowenthal E, Chapman, J, Calabrese, K, et al. Adolescent and Parent Experiences with Long-Acting Injectables in the MOCHA Study. Presented at CROI 2022.

Contacts

ViiV Healthcare enquiries:

Media enquiries:

Catherine Hartley

+44 7909 002 403

(London)

Audrey Abernathy

+1 919 605 4521

(North Carolina)

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)

Analyst/Investor enquiries:

Nick Stone

+44 (0) 7717 618834

(London)

Sonya Ghobrial

+44 (0) 7392 784784

(Consumer)

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)

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