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FDA Broadens Authorization for Eli Lilly’s COVID-19 Treatment
In other COVID news, AstraZeneca’s COVID-19 vaccine and an mRNA vaccine were similar in a real-world study, and GSK and Vir will supply the EU with 22,000 doses of their COVID-19 treatment.
FDA recently broadened the emergency use authorization for Eli Lilly and Company’s COVID-19 treatment, baricitinib, to allow for treatment without remdesivir.
Under the new authorization, providers can administer baricitinib treatment for adult and pediatric coronavirus patients two years of age or older with confirmed COVID-19 who require supplemental oxygen or invasive mechanical ventilation.
Additionally, inpatient pharmacies in the US may order one milligram and two milligram tablets of baricitinib through Eli Lilly and Company’s authorized distributors.
The agency’s previous authorization in November 2020 restricted treatment with baricitinib for use only in combination with remdesivir.
"Baricitinib in combination with remdesivir has already provided many people with a treatment option that could help prevent progression to ventilation or death and increase recovery speed for certain hospitalized patients with COVID-19 under its currently authorized use," Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines, said in the announcement.
"Today's FDA action provides physicians additional treatment regimen options for baricitinib to continue to meet the urgent medical needs posed by this pandemic,” Yuffa continued.
FDA based its decision on data from the Phase 3 COV-BARRIER study — a randomized, placebo-controlled study that compared baricitinib four milligrams once daily plus standard of care versus placebo plus standard of care.
Overall, patients who received baricitinib were less likely to progress to ventilation or death than those receiving standard of care. And the treatment also reduced the risk of death by 39 percent by Day 28.
In December 2020, Eli Lilly and Company extended the COV-BARRIER study to evaluate baricitinib in mechanically ventilated patients at baseline. The study is currently ongoing, with data expected in the coming months.
AstraZeneca COVID-19 Vaccine, mRNA Vaccine Favorable in Real-World Study
AstraZeneca recently announced that its COVID-19 vaccine, Vaxzevria, and an mRNA vaccine were similar and overall favorable in a large real-world study.
The data, published in The Lancet, cited very rare clotting disorders with both vaccines. These findings were similar to the general population and lower than in those diagnosed with COVID-19.
Additionally, the increase in thrombosis rates among individuals infected with the coronavirus was substantially higher than among those vaccinated, regardless of the vaccine used.
Rates of venous thromboembolism were eight times higher after a diagnosis of COVID-19 infection compared with the expected rate.
“This real-world study offers further evidence of the favourable benefit:risk profile of Vaxzeria and demonstrates the critical role all COVID-19 vaccines are playing in combatting the pandemic,” Sir Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said in the announcement.
In the study, researchers assessed the rates of blood clotting disorders of thromboembolism and thrombocytopenia, including very rare thrombosis with thrombocytopenia, following vaccination with an mRNA vaccine or Vaxzevria.
The analysis included 945,941 mRNA participants and 426,272 Vaxzevria participants between December 2020 and May 2021, and 222,710 COVID-19 participants identified between September 2020 and March 2021.
Notably, the data is similar to recent reports in the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Report, the UK system for collecting and monitoring information on safety concerns.
Overall, researchers identified no risk factors or definitive cause for thrombosis with thromboembolism.
GSK, Vir Biotechnology Sign Agreement with EU for COVID-19 Treatment
GSK and Vir Biotechnology recently announced that they signed a Joint Procurement Agreement with the European Commission to supply 22,000 doses of their COVID-19 treatment, sotrovimab.
Sotrovimab is a single-dose SARS-CoV-2 monoclonal antibody to treat adults and adolescents at risk of progressing to severe coronavirus.
The agreement allows participating European Union (EU) member states to quickly purchase sotrovimab following local emergency authorization and treat patients accordingly.
“This agreement with the European Commission represents a crucial step forward for treating cases of COVID-19 in participating EU Member States, as it enables access to sotrovimab for high-risk patients who have contracted the virus,” George Katzourakis, senior vice president of GSK Europe, said in the announcement.
“As the COVID-19 landscape continues to evolve and we meet new challenges — such as the Delta variant spreading across the globe — there remains an urgent need for treatment options to help those who do get sick to potentially avoid hospitalisation or death,” Katzourakis continued.
The agreement follows the positive scientific opinion of sotrovimab as a COVID-19 treatment, issued by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Additionally, the documentation to support the marketing authorization application for sotrovimab is under rolling regulatory review with the EMA.
In March, GSK and Vir Biotechnology stopped a Phase 3 trial of sotrovimab after researchers found an 85 percent reduction in hospitalization or death in patients who received the treatment.
