FDA Approves Adbry for Use in the Growing Class of Atopic Dermatitis Biologics

The FDA has approved a handful of drugs to treat atopic dermatitis recently. Among them is LEO Pharma Inc.’s Adbry (tralokinumab-ldrm), an interleukin-13 (IL-13) antagonist. According to a Zitter Insights survey, payers may take a bit of a restrictive approach in managing the drug.

On Dec. 28, the FDA approved Adbry for the treatment of people at least 18 years old with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those treatments are not advisable. The decision made it the first biologic that LEO Pharma has launched in the U.S. Recommended dosing is an initial dose of 600 mg via four 150 mg subcutaneous injections and then 300 mg every other week.

Within the class of biologics to treat atopic dermatitis, Adbry is going up against Sanofi and Regeneron Pharmaceuticals, Inc.’s injectable powerhouse Dupixent (dupilumab), an IL-4/IL-13 inhibitor indicated for use in people at least 6 years old with atopic dermatitis. The FDA initially approved it in the condition on March 28, 2017. More recently, on Jan. 14, the FDA approved two oral biologics, both Janus kinase (JAK) inhibitors: AbbVie Inc.’s Rinvoq (upadacitinib) received a label expansion to treat people at least 12 years old with the condition, and Pfizer Inc.’s newcomer Cibinqo (abrocitinib) was approved for the treatment of adults. On Sept. 21, the FDA approved Incyte Corp.’s Opzelura (ruxolitinib), also a JAK inhibitor but in cream form, for use in people at least 12 years old.

For the Managed Care Biologics and Injectables Index: Q2 2021, between May 18, 2021, and July 13, 2021, Zitter Insights polled 40 commercial payers covering 129.5 million lives. Those covering half of lives said they expected to manage Adbry to label, but those with 43% of lives said they anticipated managing it more restrictively than its label.

Zitter Insights and AIS Health are both MMIT companies.

Zitter Insights also polled 50 dermatologists during the same time frame. While about half were undecided on some of their anticipated prescribing actions for Adbry, two-thirds of them said they expected to prescribe it to treat atopic dermatitis (see chart).

For more information on the Zitter Insights data, contact Jill Brown Kettler at jbrown@aishealth.com.