{"id":8026,"date":"2022-06-19T19:29:32","date_gmt":"2022-06-20T03:29:32","guid":{"rendered":"https:\/\/store.apotheraspecialtypharmacy.com\/?p=8026"},"modified":"2023-05-10T18:07:45","modified_gmt":"2023-05-11T02:07:45","slug":"fda-approves-lilly-and-incytes-olumiant-baricitinib-as-first-and-only-systemic-medicine-for-adults-with-severe-alopecia-areata","status":"publish","type":"post","link":"https:\/\/store.apotheraspecialtypharmacy.com\/?p=8026","title":{"rendered":"FDA Approves Lilly and Incyte’s OLUMIANT (baricitinib) As First and Only Systemic Medicine for Adults with Severe Alopecia Areata"},"content":{"rendered":"

Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT\u00ae\u00a0<\/sup>(baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), available as 4-mg, 2-mg and 1-mg tablets.<\/p>\n

The recommended dose is OLUMIANT 2-mg\/day, with an increase to 4-mg\/day if treatment response is inadequate.<\/p>\n

For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4-mg\/day.<\/p>\n

Once an adequate response is achieved on 4-mg\/day, the dosage is to be decreased to 2-mg\/day.<\/p>\n

OLUMIANT is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.<\/p>\n

The approval was based on\u00a0Lilly’s BRAVE-AA1 and BRAVE-AA2 trials, the largest Phase 3 AA clinical trial program completed to date, evaluating the efficacy and safety of OLUMIANT in 1,200 adult patients with severe AA (\u226550% scalp hair loss as defined by a Severity of Alopecia Tool (SALT) score \u226550)<\/p>\n

Across the studies at 36 weeks, 17-22% of patients taking OLUMIANT 2-mg\/day and 32-35% of patients taking OLUMIANT 4-mg\/day achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo.<\/p>\n

Additionally, 11-13% of patients taking OLUMIANT 2-mg\/day and 24-26% of patients taking OLUMIANT 4-mg\/day achieved 90% or more hair coverage, compared to 1-4% of patients taking placebo; results for OLUMIANT 2-mg\/day were not statistically significant under the multiplicity control plan for BRAVE-AA2<\/p>\n

Among patients with substantial eyebrow and eyelash hair loss at baseline, improvements in eyebrow and eyelash coverage were seen for patients taking OLUMIANT 4-mg daily at 36 weeks.<\/p>\n

The BRAVE-AA clinical program evaluated the safety profile of OLUMIANT.<\/p>\n

Few patients discontinued treatment due to adverse events (average of 2.2% across both studies) in the 36-week placebo-controlled period and the majority of treatment-emergent adverse events were mild or moderate in severity<\/p>\n

The most commonly reported adverse reactions (\u22651%) were upper respiratory tract infections, headache, acne, high cholesterol levels, increases in blood markers related to the muscle, urinary tract infections, elevated liver enzyme levels, inflammation of hair follicles, fatigue, lower respiratory tract infections, nausea, genital yeast infection, low red blood cell counts, low white blood cell counts, abdominal pain, shingles and weight increase<\/p>\n

The U.S. FDA-approved labeling for OLUMIANT includes a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis<\/p>\n

OLUMIANT is a once-daily, oral JAK inhibitor\u00a0discovered by\u00a0Incyte\u00a0and licensed to\u00a0Lilly\u00a0and is available through specialty pharmacies nationwide. Lilly\u00a0also expects regulatory decisions for OLUMIANT in AA in the\u00a0European Union\u00a0and Japan\u00a0in 2022.<\/p>\n

About BRAVE-AA1 and BRAVE-AA2
\n<\/b>In these double-blind, placebo-controlled Phase 3 trials, 1,200 patients with severe AA were randomized to receive once-daily OLUMIANT 2-mg, OLUMIANT 4-mg or placebo.<\/p>\n