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FDA grants Priority Review to ViiV Healthcare’s New Drug Application for cabotegravir long-acting for prevention of HIV

Final FDA decision anticipated by 24 January 2022; if approved, cabotegravir would be the first long-acting therapy for HIV PrEP

LONDON–(BUSINESS WIRE)–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

Contacts

ViiV Healthcare
Media enquiries:

Melinda Stubbee +1 919 491 0831 (North Carolina)

Audrey Abernathy +1 919 605 4521 (North Carolina)

Catherine Hartley +44 7909 002 403 (London)

GSK enquiries:
Media enquiries:

Tim Foley +44 (0) 20 8047 5502 (London)

Kristen Neese +1 804 217 8147 (Philadelphia)

Kathleen Quinn +1 202 603 5003 (Washington DC)

Analyst/Investor enquiries:

James Dodwell +44 (0) 20 8047 2406 (London)

Mick Readey +44 (0) 7990 339653 (London)

Jeff McLaughlin +1 215 751 7002 (Philadelphia)

Frannie DeFranco +1 215 751 4855 (Philadelphia)

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options

If Approved, Lenacapavir Would be the First Capsid Inhibitor and the Only HIV-1 Treatment Option Administered Every 6 Months

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the company completed submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.

The submission is supported by data from the Phase 2/3 CAPELLA trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously every six months in combination with an optimized antiretroviral background regimen. Key data on lenacapavir will be presented during the 11th International AIDS Society (IAS) Conference on HIV Science in July 2021.

In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs. Lenacapavir, which is being studied as an every-six-month subcutaneous injection, is a potential first-in-class capsid inhibitor for the treatment of HIV-1 infection without overlapping resistance with any currently approved antiretroviral therapy (ART).

Lenacapavir is an important breakthrough innovation with the potential to be transformative for people living with multi-drug resistant HIV who have very limited treatment options,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “The filing moves us one step closer to providing an innovative treatment option that helps to address barriers to achieving viral suppression and meet the unmet needs of people living with multi-drug resistant HIV.”

Lenacapavir is being developed in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with MDR HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations. Lenacapavir is designed to inhibit HIV-1 replication by interfering with multiple, essential steps of the viral lifecycle, including capsid-mediated uptake of HIV-1 proviral DNA, virus assembly and release, and capsid core formation.

Gilead plans to submit marketing authorization applications for lenacapavir to the European Medicines Agency and other global agencies in the coming months.

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS.

About CAPELLA (NCT04150068)

CAPELLA is a Phase 2/3 double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of Gilead’s investigational, long-acting HIV-1 capsid inhibitor lenacapavir administered every 6 months as a subcutaneous injection in HTE people with MDR HIV-1 infection. CAPELLA includes men and women living with HIV-1 and is being conducted at research centers in North America, Europe and Asia.

In CAPELLA, 36 participants with multi-class HIV-1 drug resistance and a detectable viral load while on a failing regimen were randomly allocated to receive oral lenacapavir or placebo for 14 days, in addition to continuing their failing regimen (functional monotherapy). An additional 36 participants were enrolled in a separate treatment cohort. The primary endpoint was the proportion of participants randomly allocated to receive oral lenacapavir or placebo for 14 days, in addition to continuing their failing regimen, achieving ≥ 0.5 log10 copies/mL reduction from baseline in HIV-1 RNA at the end of the functional monotherapy period.

The study achieved its primary endpoint by demonstrating that a significantly higher proportion of participants randomly allocated to receive lenacapavir achieved a clinically meaningful viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those receiving placebo during the 14-day functional monotherapy period (88% vs. 17%, p<0.0001). These data were previously presented at the virtual 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021). Those who received lenacapavir (n=24) achieved statistically significantly greater mean decrease in viral load than those who received placebo (n=12) during the functional monotherapy period (-1.93 log10 copies/mL vs. -0.29 log10 copies/mL, p<0.0001). Lenacapavir was generally well-tolerated, with no serious adverse events related to study drug observed and no study drug discontinuations through the 14-day period, including no discontinuations due to adverse events. The most common adverse events observed were injection site reactions.

Following the 14-day functional monotherapy period, participants who were randomly allocated to receive lenacapavir or placebo, in addition to continuing their failing regimen, started open-label lenacapavir and an optimized background regimen, while those enrolled in a separate treatment cohort received open-label lenacapavir and an optimized background regimen on Day 1. This ongoing maintenance period of the study is evaluating the additional trial endpoints of safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen. The trial data for the first six-month period (Week 26) have been submitted to the FDA as part of the NDA filing, and will be presented at an upcoming conference.

For further information, please see https://clinicaltrials.gov/ct2/show/NCT04150068.

About Lenacapavir

Lenacapavir is a potential first-in-class, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. Lenacapavir’s multi-stage mechanism of action is distinguishable from currently approved classes of antiviral agents and is designed to provide a new avenue for the development of long-acting therapy options for people living with or at risk for HIV-1. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes.

The safety, efficacy and dosing of lenacapavir are being evaluated in multiple ongoing clinical studies. Data presented at AIDS 2020 from a completed Phase 1 study support further evaluation of lenacapavir administered subcutaneously every six-month for both HIV-1 treatment and prevention. During IDWeek 2020, the company announced plans to evaluate the use of lenacapavir as an injectable PrEP option administered every six months among cisgender women, men who have sex with men and persons of trans experience. The prevention trials have projected initiation dates in 2021.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed eleven HIV medications, including the first single tablet regimen to treat HIV and the first once-daily oral antiretroviral tablet for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere.

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, including those involving lenacapavir; the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving lenacapavir; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including FDA, European Medicines Agency or other regulatory approval of lenacapavir, and the risk that any such approvals may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and that, as a result, lenacapavir may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. All other trademarks are the property of their respective owners.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

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