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Lilly’s repurposed COVID-19 med baricitinib bags FDA emergency approval

Drug approved for emergency use in combination with Gilead's remdesivir

Eli Lilly and Incyte’s arthritis treatment baricitinib has been repurposed as a COVID-19 treatment, scoring an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) in combination with Gilead’s antiviral remdesivir.

The EUA covers baricitinib in combination with remdesivir for the treatment of hospitalised adults and paediatric patients two years or older with COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

The approval is based on data from the ACTT-2 study – sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID) – which evaluated baricitinib plus remdesivir in hospitalised COVID-19 patients, with or without oxygen requirements.

Results from this trial demonstrated that the combo treatment caused a significant reduction in the median time to recovery from eight to seven days, compared to remdesivir alone.

Patients treated with the baricitinib/remdesivir regimen were also more likely to have a better clinical status at day 15 compared to remdesivir monotherapy.

In addition, the mortality rate at day 29 was 4.7% for the baricitinib/remdesivir treatment group compared to 7.1% for those who only received remdesivir – a relative reduction of 35%.

Baricitinib is already marketed by Lilly as Olumiant, for the treatment of adults with moderate to severe rheumatoid arthritis in the US.

"Since the start of the COVID-19 pandemic, Lilly has been committed to finding potential treatments to help people around the world who've been impacted by this virus," said David A. Ricks, Lilly chairman and CEO.

"Today's FDA action for baricitinib marks the second Lilly therapy to be granted an EUA, in addition to the recent neutralising antibody EUA for high-risk non-hospitalised patients, increasing the number of treatment options for COVID-19 patients at different stages of the disease,” he added.

Lilly’s monoclonal antibody treatment bamlanivimab was also granted an EUA from the FDA for the treatment of COVID-19 earlier this month.

The EUA covers bamlanivimab 700mg for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients. It is not authorised, however, for patients who are hospitalised as a result of COVID-19 or who require oxygen therapy due to COVID-19.

According to the FDA, monoclonal antibodies like bamlanivimab could be associated with ‘worse clinical outcomes’ when given to hospitalised COVID-19 patients who require high flow oxygen or mecha

Article by
Lucy Parsons

20th November 2020

From: Regulatory

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