Combo Treatment for COVID-19 Gets Green Light

FDA approves baricitinib with remdesivir for those in the hospital with COVID-19

(RxWiki News) The US Food and Drug Administration (FDA) has approved baricitinib in combination with remdesivir to treat COVID-19.

This combination of two drugs was granted an emergency use authorization (EUA) to treat adults and children (two years old and older) who have COVID-19, are in the hospital, and need oxygen therapy or mechanical ventilation.

In a clinical trial, this combination was shown to reduce the time to recovery within 29 days after starting treatment, compared to those who were not given these drugs.

It is important to note that an EUA is different from an FDA approval. For the EUA issuance, the FDA determined it was reasonable to believe the combination of these two drugs may be effective in treating COVID-19, and the known and potential benefits outweighed the known and potential risks.

The safety and effectiveness of this combo treatment are still being studied, the FDA noted.

Baricitinib is not approved to be given on its own as a treatment for COVID-19. Baricitinib, originally approved to treat rheumatoid arthritis, works to block inflammation. It is available in tablet form.

Remdesivir is already approved by the FDA to treat COVID-19 in both adults and children (12 years of age and older) who are in the hospital. It is injected into the vein.

“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,” said Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, in a press release.

Potential side effects when both drugs are taken include serious infections, blood clots, changes in certain lab tests and allergic reactions.

The FDA issued this EUA to Eli Lilly and Company.