On July 19, 2022 Gilead Sciences and the European Commission reported that signed a new joint procurement agreement (JPA) that will ensure continued rapid and equitable access to Veklury (remdesivir) for participating Member States across the European Union (EU) and European Economic Area (EEA) (Press release, Gilead Sciences, JUL 19, 2022, View Source [SID1234616771]).
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The agreement covers purchases of Veklury over the next twelve months and has the option to be extended for an additional six months. It follows the expiration of the original JPA agreement, the first for a COVID-19 therapeutic, signed in October 2020.
"We welcome this new JPA for Veklury which will continue to help governments across Europe ensure they have rapid access to this critical treatment," said Johanna Mercier, Chief Commercial Officer, Gilead Sciences. "Veklury is the antiviral standard-of-care treatment for appropriate hospitalized patients across a spectrum of COVID-19 disease severity. It has helped hundreds of thousands of patients across Europe recover faster and reduce hospital stays, which generate savings for healthcare systems. Following the recent expanded indication to patients at risk for disease progression, Veklury now has the potential to help even more patients so we are pleased this JPA will help ensure Veklury is available for patients when they need it."
In the EU and EEA Veklury is the only antiviral indicated for the treatment of COVID-19 in adult and adolescent patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation). In December 2021, the European Commission expanded the indication for Veklury to include adults who do not require supplemental oxygen and are at an increased risk of progressing to severe COVID-19.
The expanded European conditional marketing authorization was supported by results from a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury for the treatment of COVID-19 in patients at high risk for disease progression. In this study, Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008; in the study, there were no deaths in either arm through the primary endpoint. The study was also the basis for the World Health Organization’s updated Therapeutics and COVID-19 living guideline, which now conditionally recommends Veklury for use in patients with non-severe COVID-19 at the highest risk of hospitalization.
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 the antiviral standard of care 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 drug interactions in diverse populations. It can help reduce disease progression across a broad spectrum of disease severity and enable patients to recover faster, freeing up limited hospital resources and generating savings to healthcare systems.
Veklury is a nucleotide analog that directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. In vitro laboratory testing in multiple independent studies show that Veklury continues to retain activity against SARS-CoV2 as it evolves, including the Omicron variant and its subvariants BA.1 and BA.2. As new SARS-CoV-2 variants of concern emerge around the world, Gilead continuously evaluates the effectiveness of Veklury against viral variants.
Veklury is approved or authorized for temporary use in approximately 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 (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 <30 mL/min.
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 ≤40 kg is the lyophilized powder formulation; See full Prescribing Information.
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.