We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Lilly's (LLY) Olumiant Gets Full Approval From FDA for COVID
Read MoreHide Full Article
Eli Lilly and Company (LLY - Free Report) and partner Incyte (INCY - Free Report) announced that the FDA has granted full approval to their JAK inhibitor, Olumiant (baricitinib) for treating COVID-19 in certain hospitalized adults requiring various degrees of oxygen support.
Lilly and Incyte’s Olumiant has been available in the United States for treating COVID-19 in certain hospitalized patients (pediatric as well as adults) under FDA’s Emergency Use Authorization (EUA) since November 2020. With the full approval, Olumiant (4-mg once daily) will be available or the treatment of COVID-19 in hospitalized patients who require various degrees of respiratory support, from supplemental oxygen to mechanical ventilation or extracorporeal membrane oxygenation (ECMO). However, for pediatric patients, 2 to less than 18 years, the EUA remains in place.
Lilly’s shares have risen 3.8% this year so far compared with the industry’s increase of 1.5%.
Image Source: Zacks Investment Research
The FDA’s full approval is based on data from two randomized, double-blind, placebo-controlled phase III studies, ACTT-2 and COV-BARRIER.
However, the FDA’s full approval comes with a boxed warning on its label about the risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis
Olumiant is presently approved to treat rheumatoid arthritis (RA) in several countries and authorized to treat hospitalized COVID-19 patients in approximately 15 countries. Olumiant is also approved in Europe and Japan for atopic dermatitis while it is under review in the United States for the same indication. Olumiant is also under review for severe alopecia areata.
The drug generated sales of $255.6 million for Lilly in the first quarter of 2022, up 32% on a year-over-year basis.
Some other popular JAK inhibitor medicines available are AbbVie’s (ABBV - Free Report) Rinvoq (upadacitinib) and Pfizer’s (PFE - Free Report) Xeljanz.
AbbVie’s Rinvoq is approved for RA, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. AbbVie expects Rinvoq to be its key top-line driver when generics of its blockbuster immunology medicine Humira are launched next year.
Rinvoq registered sales of $465 million in the first quarter, up 57.3% year over year.
Pfizer’s Xeljanz is approved for RA, psoriatic arthritis, ulcerative colitis and ankylosing spondylitis. Xeljanz sales declined 29% to $372 million in the first quarter.
However, neither Rinvoq nor Xeljanz are approved to treat COVID-19.
Image: Bigstock
Lilly's (LLY) Olumiant Gets Full Approval From FDA for COVID
Eli Lilly and Company (LLY - Free Report) and partner Incyte (INCY - Free Report) announced that the FDA has granted full approval to their JAK inhibitor, Olumiant (baricitinib) for treating COVID-19 in certain hospitalized adults requiring various degrees of oxygen support.
Lilly and Incyte’s Olumiant has been available in the United States for treating COVID-19 in certain hospitalized patients (pediatric as well as adults) under FDA’s Emergency Use Authorization (EUA) since November 2020. With the full approval, Olumiant (4-mg once daily) will be available or the treatment of COVID-19 in hospitalized patients who require various degrees of respiratory support, from supplemental oxygen to mechanical ventilation or extracorporeal membrane oxygenation (ECMO). However, for pediatric patients, 2 to less than 18 years, the EUA remains in place.
Lilly’s shares have risen 3.8% this year so far compared with the industry’s increase of 1.5%.
Image Source: Zacks Investment Research
The FDA’s full approval is based on data from two randomized, double-blind, placebo-controlled phase III studies, ACTT-2 and COV-BARRIER.
However, the FDA’s full approval comes with a boxed warning on its label about the risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis
Olumiant is presently approved to treat rheumatoid arthritis (RA) in several countries and authorized to treat hospitalized COVID-19 patients in approximately 15 countries. Olumiant is also approved in Europe and Japan for atopic dermatitis while it is under review in the United States for the same indication. Olumiant is also under review for severe alopecia areata.
The drug generated sales of $255.6 million for Lilly in the first quarter of 2022, up 32% on a year-over-year basis.
Some other popular JAK inhibitor medicines available are AbbVie’s (ABBV - Free Report) Rinvoq (upadacitinib) and Pfizer’s (PFE - Free Report) Xeljanz.
AbbVie’s Rinvoq is approved for RA, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. AbbVie expects Rinvoq to be its key top-line driver when generics of its blockbuster immunology medicine Humira are launched next year.
Rinvoq registered sales of $465 million in the first quarter, up 57.3% year over year.
Pfizer’s Xeljanz is approved for RA, psoriatic arthritis, ulcerative colitis and ankylosing spondylitis. Xeljanz sales declined 29% to $372 million in the first quarter.
However, neither Rinvoq nor Xeljanz are approved to treat COVID-19.
Lilly currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.