J&J's oral IL-23 drug backed for psoriasis in EU
Johnson & Johnson's oral IL-23 inhibitor Icotyde, tipped to become a future blockbuster, has been recommended as a frontline treatment for plaque psoriasis in the EU.
The EMA's human medicines committee, the CHMP, backed Icotyde (icotrokinra) as a treatment for patients aged 12 and over with moderate-to-severe psoriasis, provided they weigh at least 40kg, at its July meeting. The decision comes a few weeks after Icotyde was cleared for marketing in the US.
It is the first oral IL-23 drug to reach the market and was highlighted in this year's Drugs to Watch listing by analysts at Clarivate, who suggested it could become a $1.5 billion-a-year brand in 2031. That is dependent on approvals in additional indications and the drug continuing to outperform Bristol Myers Squibb's oral TYK2 inhibitor Sotyktu (deucravacitinib), having done so in the head-to-head ICONIC-ADVANCE 1 and 2 studies.
Injectable IL-23 inhibitors, such as J&J's Tremfya (guselkumab), AbbVie's Skyrizi (risankizumab), and Sun Pharma's Ilumya (tildrakizumab), have become widely used for psoriasis, but an oral alternative that offers similar efficacy will be welcomed by patients.
In clinical trials, around two-thirds of recipients achieve clear or almost clear skin with Icotyde, compared to 8% to 11% with placebo, and the drug also showed efficacy in patients with challenging forms of psoriasis, such as lesions affecting the scalp, genital region, hands, and feet.
J&J licensed icotrokinra from Protagonist Therapeutics in 2017 in a deal worth up to $1 billion, including an upfront payment of $50 million.
Three cholesterol drugs
The CHMP also recommended three new cholesterol-lowering drug therapies at its July meeting, namely LIB Therapeutics' injectable PCSK9 inhibitor Lyrokaul (lerodalcibep), Menarini's oral CETP inhibitor Ubeslo (obicetrapib) and combination product Evlarco (obicetrapib and ezetimibe).
Lyrokaul is a fusion protein that can be administered in smaller injection volumes compared to the current antibody-based PCSK9 inhibitors, Amgen's Repatha (evolocumab) and Sanofi/Regeneron's Praluent (alirocumab), and has been approved for hypercholesterolaemia and mixed dyslipidaemia.
Ubeslo and Evlarco, meanwhile, feature a new-generation CETP inhibitor that has overcome the limitations of earlier drugs, such as off-target toxicity and a failure to demonstrate meaningful improvements in cardiovascular outcomes. MSD, Pfizer, Eli Lilly, and Roche – which have all scrapped CETP inhibitor development programmes due to safety or efficacy issues.
Other drugs recommended for approval at the CHMP meeting included:
- Roche's Susvimo (ranibizumab) implant, a reformulation of the well-established VEGF inhibitor, for the eye disorder wet age-related macular degeneration (AMD);
- GSK's IBAT inhibitor Lynavoy (linerixibat) for cholestatic pruritus in adult patients with primary biliary cholangitis;
- Minoryx Therapeutics' PPAR gamma agonist Nezglyal (leriglitazone) for the treatment of cerebral adrenoleukodystrophy (CALD); and
- Shionogi's antiviral drug Zokovea (ensitrelvir) for post-exposure prophylaxis of COVID-19.
