In a new development, US Food and Drug Administration has issued emergency use authorization for Eli Lilly’s rheumatoid arthritis drug baricitinib and remdesivir, in combination for coronavirus. This makes it the first emergency approval given to any drug combination for COVID-19.
Previously, the drug Baricitinib has already been approved for treatment of rheumatoid arthritis by the FDA. However, research now shows that when given in combination with Gilead Sciences’ remdesivir, it can help coronavirus patients recover better.
Today, we issued an emergency use authorization (EUA) for a combination treatment for #COVID19 for hospitalized adults & children ages 2 and older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. https://t.co/srRZAR9GjV pic.twitter.com/WXVJITK6XY
— U.S. FDA (@US_FDA) November 19, 2020
The drug Remdesivir has already been given a prior full FDA approval separately to treat the viral illness as well. The new approval for the drug combination is reserved for patients suffering from severe coronavirus infection, who have been hospitalized and are receiving supplemental oxygen.
The approval comes based on data from a randomized double-blind study, which administered the drug combination in some patients and only remdesivir in others. The scientists conducting the study found that the drug combo reduced median recovery time by one day and increased the chances of survival by 35 percent, in comparison to people taking remdesivir alone.
FDA’s Patrizia Cavazzoni who is acting director of the FDA’s Center for Drug Evaluation and Research said, “The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway”.
This is not it; scientists are also working to see if the combination of baricitinib and the steroid dexamethasone may also help coronavirus patients recover sooner. Dexamethasone was also given to President Donald Trump when he got infected with the virus before US presidential elections.
Scientists at the company are also looking to see if baricitinib by itself can be a good therapeutic option for coronavirus patients.
Eli Lilly has also recently gotten emergency approval for bamlanivimab, which is a monoclonal antibody treatment for coronavirus cases which are diagnosed early. Bamlanivimab is for adults over the age of 65 who are diagnosed with mild-to-moderate Covid-19 and pediatric patients 12 years and older, who are at high risk for progressing to severe Covid-19.
.@TexasDSHS has allocated this initial shipment of bamlanivimab to acute care hospitals across Texas, including hospitals in Lubbock, with additional doses expected to be shipped each week.@LillyPad #COVID19 https://t.co/pU3mrjRNZd
— Gov. Greg Abbott (@GovAbbott) November 19, 2020
Other companies looking at potential drug therapies include; Regeneron’s antibody cocktail and dexamethasone. Both treatments have not yet received EUAs. Another drug Hydroxychloroquine was previously given FDA approval which was later rescinded after data showed it had no benefit for Covid-19 patients.
News of the FDA approval for Eli Lilly treatment sent the company stock soaring. The company stocks had been up 7% since the start of the year and then gained around 19 percent. The company revenue has also grown 1 percent as well.
The company will also manufacture and provide a million doses of this antibody treatment by the end of 2020. It is also working to increase its manufacturing capacity by next year. This is likely to increase the company stock price more in the future.
This week, FDA also issued an emergency use authorization for the first of its kind COVID-19 diagnostic test that can be used at home, without help from any healthcare provider.
— Health Units (@healthunits) November 18, 2020
The “Lucira COVID-19 All-In-One Test” Kit gives results in just 30 minutes. This means potentially millions of people can be diagnosed with ease in the comfort of their own home. The test uses nasal swab samples from people above the age 14 who are suspected of COVID-19 by their healthcare provider. The molecular test can only be used after a doctor gives you a prescription.
The test can also be used in hospitals, care centers, emergency rooms, and doctor’s offices for diagnosing people. The sample collected from nasal swabs is then put into a vial that is swirled and then placed in the test unit. After 30 minutes, you can read the results from the light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus.