FDA Approves Remdesivir Pediatric Covid-19 Treatment

As Covid-19 is still spreading like wildfire in some parts of the world and continuing to impact people including young children now, the FDA, in a major move approved the use of remdesivir pediatric Covid treatment on Monday.

Children aged 28 days and older having a body weight of at least 3 kgs (approximately 7 pounds) who have tested positive for SARS-CoV-2, and are either hospitalized or suffering from mild-to-moderate symptoms can be treated with Veklury. Thus, Remdesivir becomes the first approved antiviral agent for treating Covid-19 in the pediatric population. Omicron has been impacting children four times more than the other variants of Covid-19. Thus, the FDA has taken this step to save children below 5 who are too young to be considered for vaccination.

Earlier this antiviral agent was approved for use in children above 12 years weighing at least 40 kgs (88 pounds). The use of Veklury in patients younger than this age range was restricted to emergency use only. However, now the agency has revoked the emergency use authorization among the pediatric population.

Remdesivir was indeed the first approved drug for use on hospitalized patients with Covid-19 in October 2020. Although some conflict existed with the WHO on its approved use, the subsequent study published by the New England Journal of Medicine proved remdesivir’s efficacy. Although remdesivir reduces the risk of mortality in patients with SARS-CoV-2 infection, it cannot be considered as a substitute for vaccination in populations for who vaccines are available.

Caravan Study for Remdesivir pediatric Covid treatment:

Remdesivir is the only drug approved for treating pediatric patients with Covid-19 infection below 12 years of age even though monoclonal antibody therapy was also authorized for emergency use by the FDA.

• Caravan Study (GS-US-540-5823) was a Phase 2/3 single-arm, open-label study conducted on young patients below the age of 18 years hospitalized with Covid-19.
• The study aimed to evaluate the safety, efficacy, tolerability, and pharmacokinetics of remdesivir on 53 patients across five cohorts grouped according to age.
• The data obtained from the study indicated that remdesivir is well tolerated in young patients below the age of 18 years with a greater number of participants demonstrating signs of improvement and recovery. In the study, no new adverse or safety events were also reported.
• The data obtained from the Caravan Study was presented at the 29^th Conference on Retroviruses and Opportunistic Infections (a virtual CROI 2022) held from February 12 to 16. This interim data was also submitted to the FDA, EMA, and other regulatory bodies of the world.

About Gilead’s Veklury

Gilead Sciences Inc.’s remdesivir is an adenosine analog’s nucleotide prodrug binding to the viral RNA-dependent RNA polymerase. It inhibits viral replication by stopping RNA transcription prematurely. Thereby, it is recommended to treat patients hospitalized with severe Covid-19 symptoms. Remdesivir can also reduce the susceptibility of non-hospitalized Covid-19 patients who are at a higher risk of disease progression.

The only approved dosage form for Veklury is intravenous injection. The recommended remdesivir pediatric dose for patients having a body weight between 3.5 kg to 40 kg is a single loading dose of 5 mg/kg Veklury on Day 1 followed by 2.5 mg/kg on Day 2 onwards. For pediatric patients who weigh 40 kg and above, a single loading dose of 200 mg on the first day is recommended followed by a 100 mg once-daily maintenance dose of 100 mg from the second day onwards.

FAQs on Remdesivir pediatric Covid treatment:

What are the remdesivir side effects?

Remdesivir side effects include enhanced liver enzymes that can cause hepatic injury, allergic reactions including elevated heart rate and hypertension, decreased blood oxygen level, shortness of breath, fever, wheezing, skin rashes & swelling, excessive sweating or shivering, and nausea.

Is remdesivir safe?

Yes, after several studies, remdesivir has exhibited no other safety findings other than already known side effects and is hence thereby considered safe to use for treating patients (both adults and now pediatric patients) hospitalized with Covid-19.

Is remdesivir FDA approved for treatment of Covid-19?

Yes, FDA (Food & Drug Administration) approved the use of remdesivir to treat Covid-19 in adult patients in October 2020. FDA also approved its use in pediatric patients older than 28 days on 25^th April 2022 impacted by the Omicron variant.

What’s the list of FDA-approved drugs for Covid-19?

Following is the list of approved drugs for Covid-19:

• Paxlovid (Nirmatrelvir and Ritonavir) – Oral antiviral
• Lagevrio (Molnupiravir) – Oral antiviral
• Veklury (Remdesivir) – Intravenous antiviral
• Bebtelovimab – IV Monoclonal antibody
• Sotrovimab – IV Monoclonal antibody
• Bamlanivimab and Etesevimab – IV Monoclonal antibody
• REGEN-COV – IV Monoclonal antibody
• Actemra (Tocilizumab) – IV biological
• Olumiant (barcitinib) – Oral medication – JAK inhibitor
• Convalescent plasma