4 more psoriasis drugs on the way

• Tapinarof, from Dermavant Sciences, expects an FDA decision by May of this year.¹¹

Tapinarof is a non-steroid topical treatment. In trials, it was more effective than placebo. Trials also showed it had limited side effects, which are commonly associated with the widely used steroids.¹²

• Topical roflumilast is made by Arcutis Biotherapeutics. It expects an FDA decision in July.¹³

Roflumilast manages an enzyme called PDE4 that helps regulate inflammation in the body.¹⁴One other PDE4 inhibitor — the oral drug Otezla^® (apremilast) — is already approved for plaque psoriasis.¹⁵In trials, roflumilast significantly reduced the severity of itch compared to placebo. Itch is the most frequently reported symptom with plaque psoriasis.¹⁶

• Deucravacitinib, from Bristol Myers Squibb, expects an FDA decision by September.¹⁷

Deucravacitinib is an oral, biologic drug called a Janus kinase (JAK) inhibitor. In trials it was superior against both placebo and an existing drug (Otezla) over the course of one year.¹⁸

Analysts caution that the FDA has safety concerns for oral JAK inhibitors as a class.¹⁹However, deucravacitinib has not shown similar side effects as existing JAK inhibitors.²⁰

• Bimekizumab, from UCB, originally expected approval in October of 2021. But COVID-19-related travel restrictions prevented the FDA from inspecting the manufacturing facility as required. A new date has not been set.²¹

Bimekizumab is an injectable, biologic drug. It performed well against several standard biologic options for severe plaque psoriasis. Comparators included Humira^® (adalimumab), Stelara^® (ustekinumab) and Cosentyx^® (secukinumab).²²

Competitive environment

Something to watch is how the phase 3 trials for these drugs were designed. This could have an impact on how broadly or quickly they gain acceptance in the market.

Neither tapinarof or roflumilast were tested against existing drugs in their class. That doesn’t mean they won’t be effective. But they will be entering a topical marketplace that is dominated by existing corticosteroids and vitamin D analogs. Some of these are available as generics for as little as $1,000 per 30-day supply.²³

In contrast, both deucravacitinib and bimekizumab were found superior against standard biologic treatments. The cost of these standard treatments is high. The wholesale acquisition cost for Otezla is approximately $4,000 per month.²⁴The wholesale acquisition cost of Humira is approximately $5,000 per month.²⁵

Speaking of prices …

No prices have been announced yet for any of these new drugs. However, we do have some data on how new drugs can impact prices in the psoriasis category.

A 2020 study tracked price increases for self-administered psoriasis therapies over a decade. While the net price of some therapies more than doubled in that period, the net price of other therapies decreased. The difference? Prices came down after FDA approval of a new branded drug that competed directly with an existing drug.²⁶

This certainly suggests that competition can drive down net costs. But a lot will depend on exactly how directly each new drug lines up against an existing drug.

For example, does the new drug have the exact same indications? Is it just as safe? Can any patient use it? Every difference means the new drug is less of a direct competitor.

What happens next?

At the very least, it seems that physicians and patients will soon have new options to treat plaque psoriasis. There is some reason to hope that these new drugs will add new competitiveness to the class.

Still, there are many and varied existing treatments. These new therapies will need to be safer, more effective, or both, in order to justify any significant price premium.

For additional details concerning these new drugs, please consult the most recent issue of Drug Pipeline Insights Report.