FDA Approves Veklury for Treatment of COVID-19 in Pediatric Patients
FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.
Gilead Sciences announced on April 25, 2022 that FDA has approved a supplemental new drug application (sNDA) for Veklury (remdesivir) for the treatment of pediatric patients who are either hospitalized with COVID-19 or have mild-to-moderate COVID-19 and are considered high risk for progression to sever COVID-19, including hospitalization or death. Patients must also be older than 28 days and weigh at least 3 kg.
This approval follows the recent sNDA approval for Veklury for adults and adolescent patients who are at high risk of progression to severe COVID-19. For pediatric patients who are at high risk for COVID-19 disease progression, a three-day Veklury treatment regimen is recommended to help prevent hospitalization. For currently hospitalized pediatric patients who do not require invasive mechanical ventilation and/or ECMO, a five-day treatment course is recommended.
“This approval means that remdesivir can potentially provide meaningful clinical improvement, by reducing disease progression and helping children recover from COVID-19 more quickly,” said Amina Ahmed, MD, Atrium Health-Levine Children’s Hospital in Charlotte, NC, in a press release. “We need proven antiviral treatment options, like remdesivir, that can help treat some of the most vulnerable in our society: children.”
“The expanded indication for Veklury for the treatment of children is a testament to the safety, tolerability and efficacy profile of this therapy, which has remained the foundational antiviral for COVID-19 treatment,” added Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences. “Effective and tolerable options for children require our best science and a dedicated focus. With the recent opening of our Gilead Pediatric Center of Excellence in Dublin, which is responsible for coordinating pediatric clinical trials for treatments for HIV, hepatitis B and COVID-19, we will continue our research to help address unmet treatment needs for children.”
Source: Gilead Sciences
Texas' MD Anderson Cancer Center Creates New Cell Therapy Institute
November 11th 2024With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.
