The FDA announced today it will grant emergency use authorization to Gilead Sciences' remdesivir, a drug that showed early promise in treating coronavirus disease 2019 (COVID-19).
The FDA announced today it will grant emergency use authorization (EUA) to Gilead Sciences' remdesivir, a drug that showed early promise in treating coronavirus disease 2019 (COVID-19).
Earlier this week, preliminary data from an NIH trial found the treatment accelerated recovery in individuals with advanced COIVD-19 and lung involvement. The investigational antiviral drug is now authorized "for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease."
The FDA notes there is limited information on the safety and effectiveness of the treatment, which can only be administered intravenously by healthcare providers. Patients with low blood oxygen levels, or who need oxygen therapy, or more intensive breathing support from a mechanical ventilator fall under the "severe disease" category.
Trial results showed patients who received the treatment had a 31% faster recovery time compared with those who received placebo (P <.001). This amounted to a recovery time of 11 days in the intervention cohort compared with 15 days in the control group. “Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (P = .059),” the researchers noted.
"FDA’s emergency authorization of remdesivir...is a significant step forward in battling COVID-19 and another example of the Trump Administration moving as quickly as possible to use science to save lives,” said HHS Secretary Alex Azar.
The National Institute of Allergy and Infectious Diseases (NIAID) sponsored the Adaptive COVID-19 Treatment Trial (ACTT), which was specifically designed to incorporate additional investigative treatments as the pandemic progresses.
An independent data and safety monitoring board (DSMB) found “remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials.” The researchers defined recovery as patients being well enough for hospital discharge or returning to normal activity level.
However, the study has yet to be peer reviewed and a separate placebo-controlled multicenter study published April 29, found remdesivir offered no benefit to patients with COVID-19. “In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits,” researchers concluded.
"The known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use," the FDA stated.
Reference
Wang Y, Zhang D, Du G, et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial [published online April 29, 2020]. J Lancet. doi:10.1016/S0140-6736(20)31022-9.
Real-World Study Reveals Key Insights into DLBCL Treatment Patterns, Outcomes
April 18th 2024A recent study offers valuable insights into the characteristics, treatment patterns, and outcomes of diffuse large B-cell lymphoma (DLBCL) in patients across different lines of therapy, providing a look into the landscape of DLBCL management.
Read More
Overcoming Employment Barriers for Lasting Social Impact: Freedom House 2.0 and Pathways to Work
April 16th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our second episode, in which we learn all about Freedom House 2.0 and the Pathways to Work program.
Listen
Gene, Light Therapy Combo Shows Promise Against Prostate Cancer Cells in Proof-of-Concept Study
April 18th 2024In their preclinical model, the researchers found efficacy both in vitro and in vivo by using CRISPR-Cas9 to mimic porphyria and combining the technology with light therapy.
Read More
Making Giant Strides in Maternity Health Through Baby Steps
April 9th 2024To help celebrate and recognize National Minority Health Month, we are kicking off a special month-long podcast series with our strategic alliance partner, UPMC Health Plan. Welcome to our first episode, which is all about the Baby Steps Maternity Program and its mission to support women throughout every step of their pregnancy journey.
Listen
Collecting SDOH Data Can Assess Risk of Medical Nonadherence, Improve HEI and Star Ratings
April 18th 2024At the Academy of Managed Care Pharmacy (AMCP) 2024 annual meeting, a panel of presenters explored changes coming to Medicare that incorporate social determinants of health (SDOH) data to improve patient and health system outcomes.
Read More
Real-World Study Reveals Key Insights into DLBCL Treatment Patterns, Outcomes
April 18th 2024A recent study offers valuable insights into the characteristics, treatment patterns, and outcomes of diffuse large B-cell lymphoma (DLBCL) in patients across different lines of therapy, providing a look into the landscape of DLBCL management.
Read More
Overcoming Employment Barriers for Lasting Social Impact: Freedom House 2.0 and Pathways to Work
April 16th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our second episode, in which we learn all about Freedom House 2.0 and the Pathways to Work program.
Listen
Gene, Light Therapy Combo Shows Promise Against Prostate Cancer Cells in Proof-of-Concept Study
April 18th 2024In their preclinical model, the researchers found efficacy both in vitro and in vivo by using CRISPR-Cas9 to mimic porphyria and combining the technology with light therapy.
Read More
Making Giant Strides in Maternity Health Through Baby Steps
April 9th 2024To help celebrate and recognize National Minority Health Month, we are kicking off a special month-long podcast series with our strategic alliance partner, UPMC Health Plan. Welcome to our first episode, which is all about the Baby Steps Maternity Program and its mission to support women throughout every step of their pregnancy journey.
Listen
Collecting SDOH Data Can Assess Risk of Medical Nonadherence, Improve HEI and Star Ratings
April 18th 2024At the Academy of Managed Care Pharmacy (AMCP) 2024 annual meeting, a panel of presenters explored changes coming to Medicare that incorporate social determinants of health (SDOH) data to improve patient and health system outcomes.
Read More
2 Commerce Drive
Cranbury, NJ 08512