U.K. endorses dexamethasone in COVID-19 hours after groundbreaking data release

U.K. officials granted a world-first approval for dexamethasone in COVID-19. (Getty Images)

Right on the heels of data showing the decades-old, inexpensive steroid dexamethasone can reduce COVID-19 deaths among hospitalized patients requiring oxygen, the U.K. government granted a world-first approval. 

The nod, in COVID-19 patients who are hospitalized and requiring oxygen, including those on ventilators, came hours after government-funded research proved the drug reduced risk of death by 35% for patients on ventilators and 20% for those receiving oxygen. The medicine reduced 28-day mortality by 17% in the large study. 

Dubbed Recovery, the study was the first test worldwide to show that a treatment can significantly reduce deaths from COVID-19. Previously, a U.S. study demonstrated a shorter time to recovery for Gilead Sciences' remdesivir, but the drug has not yet proven it can help patients survive the illness. Other research hasn't worked out that well; the FDA pulled its emergency authorization for chloroquine and hydroxychloroquine after studies didn't bear out early enthusiasm for the drugs.

Free Webinar

From Patient Adherence to Manufacturing Ease - Why Softgels Make Sense for Rx

THIS WEEK: Join Thermo Fisher Scientific’s upcoming webinar to learn why softgels offer numerous benefits for Rx drug development, including enhanced bioavailability, patient compliance and easy scale-up. Register Today!

On the heels of remdesivir's recovery data, the U.S. issued an emergency use authorization for the antiviral treatment. U.S. experts are now considering whether to recommend the medicine, NIAID director Anthony Fauci told the Wall Street Journal.

Even before the Recovery results, U.K. officials had been buying additional stocks of dexamethasone. Thanks to those purchases, the government can now treat 200,000 patients from its stockpile. 

RELATED: FDA yanks chloroquine's emergency OK after data show it doesn't work against COVID-19 

The study results and U.K. approval for dexamethasone follow a fall from grace for the previously hyped hydroxychloroquine in COVID-19. After President Donald Trump and others publicly backed the drug early in the pandemic, the U.S. FDA issued an emergency use authorization based on anecdotal data. After a more complete review of data on the drug, the agency this week revoked that authorization. 

Jonathan Van-Tam, NHS deputy chief medical officer, said in a statement the dexamethasone results—plus disappointing data for hydroxychloroquine—”illustrate the power of properly conducted clinical trials and the inherent danger of assuming things work without robust data."

Meanwhile, the pharmaceutical industry is moving ahead with its COVID-19 research. The industry is testing more than 200 products in about 1,100 trials, officials said Tuesday. Research is underway on more than 130 vaccines.


Suggested Articles

The new Community trial will first test Amgen's Otezla, Takeda's Takhzyro and UCB's zilucoplan in hospitalized patients.

Indivior faces a new lawsuit from RB, its former parent company, over a scheme to market opioid addiction therapy Suboxone Film.

A new FDA effort brings cancer drug labels to life in videotaped panels with experts, debuting its first episode on Seagen's MBC med Tukysa.