Dupixent (dupilumab), the first biologic approved for atopic dermatitis (AD), hasn’t shaken up treatment of the condition completely even as it steadily gains market share, since the bulk of plans still require patients to try mostly generic topical drugs first. But more competition could be coming to this category, with the FDA set to consider four new products for AD, including three Janus kinase (JAK) inhibitors, AIS Health reported.
The FDA extended the review period to early in the third quarter of 2021 for Pfizer Inc.’s abrocitinib for the treatment of adults and adolescents with moderate to severe AD. The agency also extended review to the third quarter of Eli Lilly and Co.’s and Incyte’s supplemental New Drug Application for Olumiant (baricitinib) for the treatment of adults with moderate to severe AD, saying it wants to gather additional cost-benefit and safety data.
Meanwhile, the FDA requested additional data on LEO Pharma A/S’s biologic tralokinumab, intended for adults with moderate to severe AD, but only on a device component, not on efficacy or safety, the company said in April. Tralokinumab would offer a novel mechanism of action for AD, noted the latest quarterly Drug Pipeline Insights Report from UnitedHealth Group’s OptumRx, although it also pointed out that “efficacy appears more modest than competing existing treatment options like Dupixent.”
Finally, a topical JAK inhibitor, Incyte’s ruxolitinib, was accepted for FDA priority review in February, with a target FDA action date in late June.
“The new oral and injectable therapies may bring new formulary options compared to Dupixent,” says Mesfin Tegenu, CEO and chairman at RxParadigm. “Depending upon how these new products are priced, market forces may play a role to bring down the annual cost for Dupixent. However, for any responsible prescriber there’s an abundance of generic topical corticosteroids available for treatment.”
At Prime Therapeutics, Dupixent is preferred on the PBM’s standard formulary as a specialty medication, says April Kunze, Pharm.D., senior director of clinical program development. It is subject to utilization management, Kunze says, adding, “there has been more awareness to this category, and biologics such as Dupixent have been approved with good efficacy results.”
Meanwhile, Eucrisa (crisaborole), a steroid-free topical treatment from Anacor Pharmaceuticals, Inc., is preferred on Prime’s standard A-Series NetResults formulary with no utilization management in place, Kunze adds.
The newer agents are unlikely to shake up treatment of most patients, according to Tegenu. “Treatment starts with the more conventional options, as there is much more data available and cost is significantly lower,” he says.
by Jane Anderson