Back to top

Image: Shutterstock

Lilly/Incyte's Olumiant Gets FDA Emergency Nod for COVID-19

Read MoreHide Full Article

Eli Lilly & Company (LLY - Free Report) and partner Incyte (INCY - Free Report) announced that the FDA has granted Emergency Use Authorization (“EUA”) to their rheumatoid arthritis drug, Olumiant (baricitinib) in combination with Gilead’s (GILD - Free Report) Veklury (remdesivir) for treating hospitalized patients with COVID-19 infection. The combination regimen also received EUA for use in pediatric patients, aged two years or older, with suspected or laboratory confirmed COVID-19 requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

The treatment regimen is presumably the first to receive an EUA for hospitalized COVID-19 pediatric patient as young as two years.

Please note that Olumiant is not approved for treating COVID-19 in the United States in any setting. The recommended dose of Olumiant per the EUA is 4-mg once daily for 14 days or until hospital discharge.

The EUA was granted based on data from the phase III study — ACTT-2 — conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The study compared Olumiant plus Veklury to Veklury alone for efficacy and safety endpoints. Data from the study showed that the combination regimen reduced median recovery time by one day, which was statistically significant. Moreover, proportion of patients who progressed to ventilation or died by day 29 despite treatment were 23% for the combination regimen compared to 28% for Veklury alone. Adverse events and serious adverse events were also observed in lower proportion of patients for the combination regimen compared to Veklury alone.

Lilly is conducting separate late-stage studies in Europe, Asia and Latin America to evaluate Olumiant, a JAK1/JAK2 inhibitor, as a potential treatment for hospitalized patients diagnosed with COVID-19.

Shares of Lilly have increased 9.2% so far this year against the industry’s decrease of 1.3%.

Apart from Olumiant, Lilly also received EUA for its antibody drug, bamlanivimab (LY-CoV555) as a monotherapy last week. The drug is authorized for the treatment of recently diagnosed mild-to-moderate COVID-19 illness at high risk of progressing to severe COVID-19 or hospitalization. The approval was based on data from the BLAZE-1 study. The study is also evaluating a combination of bamlanivimab with Lilly’s another COVID-19 antibody candidate etesevimab in COVID-19 patients recently diagnosed with COVID-19 in the ambulatory (non-hospitalized) setting. Lilly is also evaluating bamlanivimab for the prevention (prophylaxis) of COVID-19 in residents and staff at long-term care facilities in a late-stage BLAZE-2 study.

With rising number of coronavirus cases as well as hospitalized patients in the United States and two authorized drugs for hospitalized COVID-19 patients, Lilly’s revenues might get a boost in the upcoming quarters.

We note that Pfizer (PFE - Free Report) and its partner BioNTech reported 95% efficacy rate for their coronavirus vaccine candidate and may file for an EUA within few days. A few other companies may receive EUA for their vaccine candidate by year-end. While successful development of vaccine can help stop the spread of the infection, development of therapeutic antibodies or antiviral drugs will help treating infected patients. Several pharma/biotech companies are engaged in bringing a treatment/vaccine for COVID-19. Successful development of these candidates are likely to help in faster recovery of the U.S. economy as lower infection rates will help removal of restrictions.

Zacks Rank

Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

5 Stocks Set to Double

Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.

Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.

Today, See These 5 Potential Home Runs >>

Published in