1. What’s happening
A just-approved psoriasis pill from J&J is poised to disrupt a multi-billion-dollar market currently dominated by conventional biologics.
2. What’s the big deal
The Food and Drug Administration approved Johnson & Johnson and Protagonist Therapeutics’ oral IL-23 inhibitor icotrokinra for moderate-to-severe plaque psoriasis in patients 12 and older. J&J will market the drug under brand name Icotyde, with commercial launch expected this year.
- The first-of-its-kind oral could open up the market by unlocking access to those who are needle-hesitant and other new patients.
- J&J CEO Joaquin Duato said in January that existing therapies have only penetrated 30% to 40% of the IL-23 sector.
- But the once-daily pill could also grab sales from rivals and J&J’s own Tremfya, currently a $5-billion drug.
3. What’s at stake
Psoriasis impacts more than 8 million Americans. In Phase 3 studies, about 70% of patients taking Icotyde achieved “clear or almost clear skin.”
- “The approval of a novel systemic therapy changes the conversation about treatment options for our community,” states Leah Howard, president and CEO of the National Psoriasis Foundation.
- Interleukin (IL) inhibitors, which also include AbbVie’s Skyrizi and J&J’s Tremfya, target chemical signals that can trigger an immune response. J&J’s Stelara targets IL-12/23.
- Existing IL-23 meds are available as subcutaneous injections, whereas Icotyde marks the first IL-23 in pill form.
4. What it means for commercial execs
J&J’s closely watched drug could quickly distinguish itself in this sector.
- J&J forecasts the drug to bring in more than $5 billion in peak sales, and Duato said the company will seek to maximize both the new oral and biologic Tremfya.
- Beghou Partner Robert Rouse, who heads the consultancy’s market access practice, doesn’t expect Icotyde to cannibalize sales from its older injectable but rather to expand the market.
- J&J, which didn't immediately disclose the price of the new drug, could encounter resistance from payers, who may question the pill’s efficacy, tolerability, and safety compared to the biologic, Rouse said.
5. What’s next
Icotyde is being investigated in psoriatic arthritis, ulcerative colitis, and Crohn’s disease -- indications in which its IL-23 rivals also compete.
- Immunology drugmakers have been doing more product messaging, and less disease education, to drive consumers to their brand.com sites.
- With injectable IL-23 drugs going for six-figure list prices, growing the market could increase costs substantially for insurers.
- The immuno-matchup is one of several potential launches this year where oral drugs will vie to reshape competitive landscapes.