Wins for AstraZeneca: Diabetes Drug Approved for Teens, Covid Vaccine Effective against Delta Variant
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The FDA has now approved AstraZeneca's convenient once-a-week glucose lowering drug for 10 to 17-year-olds with type 2 diabetes. In a pivotal trial, the Bydureon BCise injection significantly reduced blood sugar in the adolescents receiving the drug, as measured by HbA1c.
This is the first once-weekly injection of a GLP-1 receptor agonist approved for older children. The convenience and ease of use should help the drug fill the gap in treatment options for this age group.
Type 2 Diabetes was once referred to as “adult-onset diabetes,” but the term has grown obsolete in the face of the rising number of children and teens being diagnosed with the disease. Experts point to the obesity epidemic in America as the likely culprit.
“The US FDA approval is an important milestone for the treatment of children with type 2 diabetes. BYDUREON BCise brings an important new therapeutic option to physicians caring for children with this chronic disease that can lead to serious long-term issues if not adequately treated,” said William Tamborlane, MD, Department of Pediatrics, Yale School of Medicine.
Bydureon BCise, the extended-release formulation of exenatide, was first approved in the US in 2017. AstraZeneca scooped up the original formula in 2012 when Bristol-Myers Squibb acquired Amylin, the company that snagged US approval earlier that year. AZ dropped about $3.4 billion in cash to expand its diabetes collaboration with BMS and take on the drug.
While that approval is exciting for T2D teens and families, the AstraZeneca drug that’s claimed the globe's attention this year is the company's COVID-19 vaccine, developed with Oxford University. While not approved for use in the US, the single-shot vaccine is being administered primarily under emergency authorization in many EU countries, South America, Canada, Mexico, Africa, Australia, and some of Asia.
Now, as the dangerous Delta variant sweeps the globe, AstraZeneca’s Vaxzevria is proving it's still up to the task of preventing severe illness. According to a study conducted in Canada, one dose of the vaccine was 87% effective against hospitalization or death related to SARS-CoV-2.
“With different variants threatening to disrupt our route out of the pandemic, this real-world evidence shows that Vaxzevria, along with other vaccines used in Canada, provides a high level of protection against the most serious forms of the disease, even after just one shot," said Mene Pangalos, Executive Vice President, Biopharmaceuticals R&D.
When it comes to preventing symptomatic disease, the effectiveness did wane against the delta variant. However, a study posted in the New England Journal of Medicine found that the efficacy was much higher with two doses, 67% after two doses versus 30.7% with just one. This could be cause for a formal recommendation of two doses of AZ’s vaccine. Pfizer-BioNTech's RNA vaccine was also reviewed and showed 88% efficacy against the delta variant after two doses, which is the recommended schedule.
Only 13.4% of our world has been fully vaccinated at this point; 29.08 million doses are administered each day. An alarming 1.1% of the population in low-income countries has received at least one dose. Over 64 million people have received AstraZeneca's Vaxzevria.