European Commission Grants Expanded Marketing Authorization for Gilead’s Biktarvy® for the Treatment of HIV in Pediatric Populations

Rhea-AI Summary

Gilead Sciences (GILD) announced the European Commission's authorization of a new low-dose tablet form of Biktarvy for HIV treatment in virologically suppressed children aged two years and older, weighing at least 14 kg. This marks the first pediatric approval for Biktarvy in the EU, addressing a significant unmet need for HIV treatment in children. The decision is based on positive results from a clinical study, showing high rates of virological suppression among participants. Biktarvy combines three antiretroviral drugs into a single tablet and is indicated for use without prior evidence of viral resistance.

Positive

• European Commission approved Biktarvy for children, addressing unmet needs.
• Clinical study shows 98% virological suppression in older children and adolescents after 48 weeks.
• First pediatric approval for Biktarvy in the EU, potentially expanding market and revenue.

Negative

• None.

– EC Authorizes a Low-Dose Tablet for HIV Treatment in Virologically Suppressed Children at Least Two Years of Age and Weighing at Least 14 kg, Helping to Address a Critical Unmet Need –

– Biktarvy Provides an Effective Therapy Choice for a Diverse Range of People Living with HIV, including Children with Limited Treatment Options –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has authorized a new low-dose tablet dosage form of Biktarvy^® (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) and an extension of the indication for Biktarvy to treat HIV infection in virologically suppressed children who are at least two years of age and weigh at least 14 kg. The European Marketing Authorization is the first pediatric approval for Biktarvy in the European Union (EU) and applies to all 27 member states of the EU, as well as Norway, Iceland and Liechtenstein.

“The European Commission’s approval is a significant milestone to address what is sadly an important unmet need, namely children with HIV requiring new treatment options,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “Additional therapy choices help to ensure children can access care and expand their HIV treatment options, which helps advance the collective efforts to overcome the HIV epidemic. Through the Gilead Global Pediatric Center of Excellence, we are committed to applying our decades of antiviral expertise to drive innovation in pediatric HIV research.”

While there have been many advances in the treatment of HIV in children and adolescents, there remains a need to prioritize, evaluate and develop options for the millions of the children worldwide. In 2021, an estimated 800,000 children under the age of 19 living with HIV were still not receiving HIV treatment. Children comprised 4% of people with HIV in 2021 but 15% of AIDS-related deaths, and the gap in HIV treatment coverage between children and adults is increasing rather than narrowing.

The authorization of an extended indication and line extension for Biktarvy for the treatment of HIV in children at least two years of age and weighing at least 14 kg is based on an open-label study (NCT02881320), which found Biktarvy to be effective and generally well-tolerated through 24 weeks in virologically suppressed adolescents and children with HIV. In Study 1474, treatment outcomes with Biktarvy were evaluated in virologically suppressed adolescents between the ages of 12 to less than 18 years weighing at least 35 kg (treatment cohort 1, N=50) and in virologically suppressed children between the ages of 6 to less than 12 years weighing at least 25 kg (treatment cohort 2, N=50). Treatment outcomes with Biktarvy were also evaluated in virologically suppressed children at least 2 years of age and weighing at least 14 kg to less than 25 kg (treatment cohort 3, N=22). At Week 2 or Week 4, select study participants from the three treatment cohorts underwent an intensive pharmacokinetic (PK) evaluation to confirm the dose to be administered in each treatment cohort. All participants from the three treatment cohorts went on to receive Biktarvy for 48 weeks. Beyond Week 48, participants can receive Biktarvy in an active open-label extension phase for up to 96 weeks.

After switching to Biktarvy, 98% (49/50) of participants in treatment cohort 1 remained suppressed (HIV-1 RNA < 50 copies/mL) at Week 48. After switching to Biktarvy, 98% (49/50) of participants in treatment cohort 2 remained suppressed (HIV-1 RNA < 50 copies/mL) at Week 48. After switching to Biktarvy, 91% (20/22) of participants in treatment cohort 3 remained virologically suppressed at Week 24. In this study, no new adverse reactions have been observed in pediatric subjects aged 2 years and older living with HIV-1 as compared to those observed in adults.

Biktarvy is indicated in the EU for the treatment of HIV infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir. For important safety information for Biktarvy, including dosing and method of administration, special warnings, drug interactions and adverse drug reactions, please see the Summary of Product Characteristics (SmPC) for Biktarvy, available from the European Medicines Agency website at www.ema.europa.eu.

Biktarvy does not cure HIV or AIDS.

About Pediatric HIV

Each day in 2021 approximately 850 children became infected with HIV and approximately 301 children died from AIDS related causes, mainly due to inadequate access to HIV care and treatment services. About 72 percent of these mostly preventable deaths occurred among children under 10 years old. Newer formulations with appropriate dosing for children and adolescents represent an unmet need that is an important part of the considerations associated with long-term health and wellness for people who live with HIV. Gilead has partnered with several global organizations and initiatives to ensure that we are optimizing and closing treatment gaps for children and adolescents in need so that ultimately, we can end the epidemic.

About Biktarvy

Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines.

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 12 HIV medications, including the first single-tablet regimen to treat HIV, and the first antiretroviral for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection, and the first, long-acting injectable HIV treatment medication administered twice-yearly. Our 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 was recognized as the number one philanthropic funder of HIV-related programs in a report released by Funders Concerned About AIDS.

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, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Biktarvy; the risk that physicians may not see the benefits of prescribing Biktarvy; 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 September 30, 2022, 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.

Full Summary of Product Characteristics for Biktarvy are available from the EMA website at www.ema.europa.eu.

Biktarvy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221128005858/en/

Jacquie Ross, Investors

investor_relations@gilead.com

Brian Plummer, Media

brian.plummer@gilead.com

Source: Gilead Sciences, Inc.

FAQ

What is the significance of the European Commission's approval for Gilead's Biktarvy?

The approval allows Biktarvy to be used for HIV treatment in children aged at least two years and weighing 14 kg, addressing an important unmet need for pediatric HIV treatment in the EU.

What were the results of the clinical study for Biktarvy's pediatric use?

The study showed that 98% of older children and adolescents remained virologically suppressed after 48 weeks on Biktarvy, indicating its effectiveness in managing HIV.

What age and weight requirements are there for Biktarvy use in children?

Biktarvy is authorized for use in virologically suppressed children who are at least two years old and weigh at least 14 kg.

How does Biktarvy work for HIV treatment?

Biktarvy combines three antiretrovirals into a single tablet, providing an efficient treatment option with a once-daily dosing regimen.

What impact does this approval have on Gilead's market presence?

This approval could expand Gilead's market presence in pediatric HIV treatment, potentially increasing revenue from the product in the EU.