CHMP Adopts Positive Opinion to Extend Indication of Veklury(R) (Remdesivir) for the Treatment of Pediatric Patients with COVID-19

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-- If Granted by the European Commission, Veklury Will Become the First and Only Authorized Antiviral Treatment for Pediatric Patients Under 12 Years of Age in the European Union --

FOSTER CITY, Calif.Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion to extend the indication of Veklury(R) (remdesivir) for the treatment of pediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 and pediatric patients (4 weeks of age and older and weighing at least 3 kg) with SARS-CoV-2 with pneumonia who require supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment). The European Commission (EC) will review the CHMP recommendation, and if adopted, Veklury will be the only authorized COVID-19 treatment for adolescents at high risk of progressing to severe COVID-19 and pediatric patients with COVID-19 requiring supplemental oxygen.

"As the pandemic persists, there remains a critical need for proven and effective antiviral therapies like Veklury that can treat some of the most vulnerable in our society," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "We are proud of today's CHMP opinion that represents a positive step toward bridging the treatment gap for children and helping them recover from COVID-19 more quickly."

This positive opinion was based on results from the ongoing CARAVAN Phase 2/3 study, which demonstrated Veklury was generally well-tolerated among pediatric patients hospitalized with COVID-19, with a high proportion of participants showing clinical improvement and recovery, as well as data from trials in adults. Of the 53 pediatric patients enrolled in the CARAVAN study, no new safety signals were apparent for patients treated with Veklury. Overall, 75% and 85% showed clinical improvement (>=2 point increase on an ordinal scale) at Day 10 and last assessment, respectively, while 60% and 83% were discharged by Day 10 and Day 30, respectively. In the study, 38 patients (72%) experienced adverse events (AEs), with 11 patients (21%) experiencing serious adverse events (SAEs) that were determined not to be study-drug related, including three participant deaths, which were consistent with the patients' underlying medical conditions prior to study entry or with COVID-19 during hospitalization.

"As the COVID-19 pandemic evolves, it's important to have effective treatments with well-established safety profiles, including for the vulnerable groups like children to help them recover faster from COVID-19," said Pablo Rojo, MD, PhD, Pediatric Infectious Diseases Specialist of Hospital 12 de Octubre, Madrid, Spain and Associate Professor of Complutense University, Madrid, Spain. "Therefore, the medical community welcomes this CHMP positive opinion for Veklury in pediatric patients and looks forward to the EC decision."

In the European Economic Area (EEA), Veklury is the only antiviral indicated for both the treatment of COVID-19 in adult patients who do not require supplemental oxygen and are at increased risk of developing severe COVID-19, as well as adults and adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment).

About Veklury

Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company's antiviral research. Veklury is a foundation for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury has an established safety profile and minimal known drug interactions in diverse populations. It can help reduce disease progression across a spectrum of disease severity and enable patients to recover faster, freeing up limited hospital resources and saving healthcare systems money.

Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro analyses, Veklury retains antiviral activity against Omicron subvariants BA.2.12.2, BA.4 and BA.5, which are currently the most common circulating variants. Data continue to confirm that Veklury retains antiviral activity against all Omicron subvariants analyzed to date. Gilead continuously evaluates the activity of Veklury against new SARS-CoV-2 variants of concern as they emerge around the world.

Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 11 million patients around the world, including more than 7 million people in 127 middle- and low-income countries through Gilead's voluntary licensing program. These licenses currently remain royalty-free, reflecting Gilead's existing commitment to enabling broad patient access to remdesivir.

U.S. Indication for Veklury

Veklury(R) (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (>=28 days old and weighing >=3 kg) with positive results of SARS-CoV-2 viral testing, who are:

  • Hospitalized, or
  • Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

For more information, please see the U.S. full Prescribing Information available at www.gilead.com.

U.S. Important Safety Information for Veklury

Contraindication

Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components.

Warnings and precautions

  • Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of Veklury; most occurred within one hour. Monitor patients during infusion and observe for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time up to 120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue Veklury and initiate appropriate treatment (see Contraindications).
  • Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received Veklury; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing Veklury if ALT levels increase to >10x ULN. Discontinue Veklury if ALT elevation is accompanied by signs or symptoms of liver inflammation.
  • Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of Veklury with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in antiviral activity of Veklury.

Adverse reactions

  • The most common adverse reaction (>=5% all grades) was nausea.
  • The most common lab abnormalities (>=5% all grades) were increases in ALT and AST.

Drug interactions

  • Drug interaction trials of Veklury and other concomitant medications have not been conducted in humans.

Dosage and administration

  • Dosage: For adults and pediatric patients weighing >=40 kg: 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2 administered only via intravenous infusion. For pediatric patients >=28 days and weighing >=3 kg: 5 mg/kg on Day 1, followed by once-daily maintenance doses of 2.5 mg/kg from Day 2, administered only via intravenous infusion.
  • Treatment duration:
    • For hospitalized patients requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days. Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19.
    • For hospitalized patients not requiring invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days.
    • For non-hospitalized patients diagnosed with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days. Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset.
  • Testing prior to and during treatment: Perform eGFR, hepatic laboratory and prothrombin time testing prior to initiating Veklury and during use as clinically appropriate.
  • Renal impairment: Veklury is not recommended in individuals with eGFR

Dose preparation and administration:

  • There are two different formulations of Veklury: Veklury for injection (supplied as 100 mg lyophilized powder in vial) and Veklury injection (supplied as 100 mg/20 mL [5 mg/mL] solution in vial). The only approved dosage form for pediatric patients weighing 3 kg to
  • Administration should take place only under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible.

Pregnancy and lactation

  • Pregnancy: A pregnancy registry has been established. There are insufficient human data on the use of Veklury during pregnancy. COVID-19 is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease and fetal death.
  • Lactation: It is not known whether Veklury can pass into breast milk. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

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. 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 effectively manage the supply and distribution of Veklury; Gilead's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Veklury; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the EC may not grant marketing authorization for Veklury for treatment of pediatric patients with COVID-19 in a timely manner or at all; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; 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 year ended June 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 involve risks and uncertainties 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.

U.S. full Prescribing Information for Veklury is available at www.gilead.com.

Veklury, 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.

Jacquie Ross, Investors
(408) 656-8793

Nicole Rodriguez, Media
(650) 235-2493

Source: Gilead Sciences, Inc.