Benzinga | Jan 14, 2022 01:11PM EST

AbbVie Says FDA Approves RINVOQ To Treat Adults, Children 12 Years And Older With Refractory, Moderate To Severe Atopic Dermatitis

AbbVie (NYSE:ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ(r) (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended.1 RINVOQ 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg.1 In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily.1

"Early in my career as an allergist, I saw how relentless the itch and rash could be for my patients with moderate to severe atopic dermatitis yet had limited options to offer those whose disease could not be adequately controlled with systemic therapy," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "This additional approval for RINVOQ provides a once-daily oral option that can significantly improve the debilitating itch and skin symptoms of atopic dermatitis. It's also a proud moment for AbbVie as we continue our efforts to improve care in this disease state and other chronic, immune-mediated conditions."

The FDA approval is supported by efficacy and safety data from one of the largest registrational Phase 3 programs for atopic dermatitis with more than 2,500 patients evaluated across three studies. Approximately 52 percent of the patients had prior exposure to systemic atopic dermatitis treatment. These studies evaluated the efficacy and safety of RINVOQ monotherapy (Measure Up 1 and 2) and with topical corticosteroids (AD Up), compared to placebo, in adults and children 12 years of age and older with moderate to severe atopic dermatitis.2-3

"Despite available therapies, many people with moderate to severe atopic dermatitis are caught in an endless cycle of itching and scratching," said Emma Guttman-Yassky, M.D., Ph.D., Waldman Professor and System Chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City.* "In clinical trials, upadacitinib showed a robust response across skin and itch symptoms that may help evolve treatment goals for those who have not achieved adequate control of their disease. And as an oral pill with two dose strengths, upadacitinib is a welcome addition to the toolbox of clinicians who are striving to make a significant difference for their patients with moderate to severe atopic dermatitis."

Clinical Response at Week 161-3

* Across the three atopic dermatitis pivotal studies, RINVOQ (15 mg and 30 mg, once daily) monotherapy and with topical corticosteroids met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance (EASI 90 and 100).

Week 16 Data

Measure Up 1 (MU1) Measure Up 2 (MU2) AD Up (AU)

RINVOQRINVOQ RINVOQRINVOQ RINVOQRINVOQ Placebo Placebo Placebo 15 mg 30 mg 15 mg 30 mg 15 mg 30 mg plus plus plus TCS TCS TCS (n= (n= (n= (n= 281) 285) (n=281)276) 282) (n=278)(n= (n= 300) 297) (n=304)

EASI 75&# 70% 80% 16% 60% 73% 13% 65% 77% 26% x2A;

vIGA-AD 0/148% 62% 8% 39% 52% 5% 40% 59% 11% *

EASI 90 53% 66% 8% 42% 58% 5% 43% 63% 13%

12%&# EASI 100 17% 27% 2% 14% 19% 1% x2A;&#23% 1% x2A;

Worst Pruritus 52% 60% 12% 42% 60% 9% 52% 64% 15% NRS ?4

*Co-primary endpoints were EASI 75 and vIGA-AD 0/1 at week 16. Not all secondary endpoints are shown.

**Endpoint not controlled for multiplicity.

EASI 75 is defined as at least a 75 percent reduction in Eczema Area and Severity Index. EASI 90 and 100 are defined as at least 90 percent or 100 percent reduction in Eczema Area and Severity Index.

vIGA-AD 0/1 is defined as a validated Investigator Global Assessment for Atopic Dermatitis of clear or almost clear (0/1) with at least two grades of reduction from baseline.

Worst Pruritus NRS ?4 is defined as the proportion of subjects achieving an improvement in Worst Pruritus Numerical Rating Scale (NRS) ?4 for subjects with Worst Pruritus NRS score ?4 at baseline.

Itch Reduction1-3

* In all three studies, a significant improvement in itch (Worst Pruritus NRS ?4) was observed as early as week one, compared to placebo.

Safety1-3

* Overall, the safety profile observed in patients with atopic dermatitis treated with RINVOQ 15 mg or 30 mg was similar to the safety profile observed in patients with rheumatoid arthritis. Other specific adverse reactions reported in atopic dermatitis patients included eczema herpeticum/Kaposi's varicelliform eruption.

* RINVOQ may cause serious side effects, including: Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Increased risk of death in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor. Cancer and immune system problems. RINVOQ may increase your risk of certain cancers, including lymphoma, skin, and lung cancer, as these can happen. Current or past smokers are at higher risk. Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor, especially in current or past smokers. Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. This has happened more often in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor.

Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ.

Other serious side effects include serious allergic reactions, tears in the stomach or intestines and changes in certain laboratory test results.

Patient Access and Support

AbbVie is committed to helping people access RINVOQ and other medicines, including offering a patient support program and a co-pay card that may reduce out-of-pocket costs to as little as $5 per month for eligible, commercially-insured patients. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides RINVOQ at no charge to those who qualify. More information about this assistance program can be found on www.AbbVie.com/myAbbVieAssist.