Monday, October 18, 2021

Lilly scores FDA emergency authorization for Olumiant in COVID-19, its 2nd therapeutic option


While the list of authorized medicines to treat COVID-19 remains quite short, with a new nod this week, Eli Lilly stands alone in having two therapeutic offerings.

Lilly’s Olumiant, already approved as a rheumatoid arthritis treatment, scored an FDA emergency use authorization in combination with Gilead’s Veklury in COVID-19 patients who are hospitalized and needing oxygen. Lilly accelerated its research on the medicine early in the pandemic after an AI analysis made the case for the drug.

The FDA’s decision follows a U.S. government study that showed that the combo of Olumiant and Veklury—also known as remdesivir—cut hospitalized patients’ recovery time by 12.5% over Veklury alone. The combo improved the odds of clinical improvement by 30% after 15 days of treatment, as well. The Olumiant regimen helped patients who needed oxygen—but not high-flow oxygen or mechanical ventilation—the most, Lilly said. 

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While limited supplies for therapeutics, testing, and personal protective equipment have been an ongoing concern during the pandemic, Lilly Bio-Medicines president Patrik Jonsson previously said the company is “extremely well-positioned” to supply its medicine if granted an authorization. The drug is a small molecule that’s easy to produce and already used widely all over the world, he said.

RELATED: Eli Lilly wins FDA’s emergency nod for COVID-19 antibody—but, thanks to mixed data, it’s limited 

This week’s authorization follows Lilly’s emergency nod for antibody bamlanivimab earlier this month. The FDA endorsed the med in patients who are newly diagnosed with COVID-19 and have mild to moderate symptoms, plus who are at risk of progressing to severe disease. Just this week, Lilly partnered with Samsung to boost production for the antibody. The company aims to make 1 million doses this year and many more in 2021. 

The newly authorized combo of Olumiant and Veklury represents an important treatment regimen for severe patients, who aren’t included in Eli Lilly’s emergency use authorization for bamlanivimab. Gilead’s remdesivir is approved in hospitalized patients, but there’s been an ongoing debate in recent weeks over its efficacy. 

After a World Health Organization trial last month found the medicine “appeared to have little or no effect” in patients hospitalized with COVID-19, the international agency this week issued a conditional recommendation against the medicine. Jozef Kesecioglu, president of the European Society of Intensive Care Medicine, recently recommended against remdesivir’s use in the intensive care setting in an interview with Reuters. 

RELATED: Gilead gets WHO cold shoulder for remdesivir in COVID-19, launches speedy defense

Still, Veklury has become the standard of care in hospitalized patients, Gilead said upon its approval last month. The company has taken issue with the WHO study, saying that because the trial prioritized broad access, there were so many variables in the patient population that it’s “unclear if any conclusive findings can be drawn from the study results.” Veklury generated $873 million during the third quarter after its own emergency use authorization in early May.



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