Lerodalcibep

The EMA's drug advisory panel backed a dozen medicines for approval at its July meeting, including Johnson & Johnson's IL-23 antagonist Icotyde (icotrokinra) for plaque psoriasis, Roche's ocular implant Susvimo (rabinizumab) for wet age-related macular degeneration (wAMD), and several cholesterol-lowering therapies.Among the more closely watched decisions, the Committee for Medicinal Products for Human Use (CHMP) recommended Icotyde for adults and adolescents aged 12 years and older with moderate-to-severe plaque psoriasis. If approved by the European Commission, Icotyde would be the first oral medicine targeting the Il-23 receptor available in the region, and expand a class that is dominated by injectables at the moment.The drug was approved in the US in March, with J&J recently saying its product is off to a strong commercial start. For related analysis, see Physician Views Results: J&J's Icotyde may have an edge on Takeda's TYK2 hopeful and Spotlight On: As Stelara fades, J&J's IL-23 tag team steps up.The CHMP recommendation was supported by four Phase III trials involving roughly 2500 patients. Across three studies, between 50% and 57% of patients achieved at least a 90% reduction in Psoriasis Area and Severity Index (PASI 90) scores after 16 weeks, versus between 1% and 4% of placebo recipients. Additionally, 65% to 71% of those given Icotyde achieved clear or almost clear skin, compared with 8% to 11% for placebo.Twice-yearly refillsMeanwhile, the Susvimo recommendation covers its use in adults with wAMD whose disease has stabilised following intravitreal anti-VEGF therapy. The treatment combines ranibizumab, which blocks VEGF, with a surgically implanted refillable ocular device designed to continuously release the drug.The implant is refilled every six months and would reduce the burden of monthly intravitreal injections that have been the standard for ranibizumab-treated patients since the drug was first approved in Europe nearly 20 years ago. If ultimately cleared by the European Commission, Susvimo would become the first implant of its kind approved in the EU.The recommendation was based on a Phase III study of 415 patients showing that Susvimo maintained visual and anatomical outcomes comparable to monthly ranibizumab injections. Common side effects included iritis, conjunctival bleb leak, cataract, vitreous floaters, conjunctival haemorrhage, conjunctival hyperaemia, eye pain and headache.Originally approved in the US for wAMD in 2021, Susvimo has since had its label expanded there to include diabetic macular oedema and diabetic retinopathy.Trio of anti-cholesterol drugsCHMP also backed approval of several cholesterol treatments for adults, including NewAmsterdam Pharma and Menarini's Ubeslo, a once-daily oral non-statin therapy containing low-dose CETP inhibitor obicetrapib, as well as Evlarco, a fixed-dose combination containing obicetrapib plus ezetimibe.Those positive opinions recommend the drugs for patients with primary hypercholesterolemia, both heterozygous familial and non-familial or mixed dyslipidemia based on Phase III data from the BROADWAY, BROOKLYN and TANDEM trials, which demonstrated significant LDL-C reductions reaching up to 40% with Ubeslo monotherapy and about 50% with Evlarco, when compared to placebo (see – KOL Views Q&A: NewAmsterdam's obicetrapib will elbow into LDL space pending two unknowns, says leading cardiologist).CHMP also adopted a positive opinion for LIB Therapeutics' Lyrokaul (lerodalcibep), an injection that patients can self-administer monthly. The third-generation PCSK9 inhibitor was approved by the FDA in December as Lerochol, based on data from the Phase III LIBerate programme showing sustained LDL-C reductions of 60% or more in patients with or at high risk of cardiovascular disease, and 50% or more in those with heterozygous familial hypercholesterolemia who have more severe LDL-C elevations.A first for cALDAmong medicines for rare diseases, CHMP recommended approval under exceptional circumstances for Minoryx Therapeutics and Neuraxpharm's Nezglyal (leriglitazone) to treat cerebral adrenoleukodystrophy (cALD) in patients aged two to 12 years with gadolinium-negative brain lesions.The opinion was based on the Phase II/III NEXUS study, where Nezglyal achieved the primary endpoint of clinical and radiological arrested disease at week 96 or at a visit prior to haematopoietic stem cell transplant, as well as additional real-world evidence from compassionate-use programmes.If regulators give the green light, expected in September, Nezglyal would become the first pharmacological treatment for cALD in the EU.Rare disease snubThe committee also issued negative opinions for three applications, including for Zevra Therapeutics' Meplyffa (arimoclomol citrate), which the company had been seeking approval for to treat Niemann-Pick disease type C in patients aged two years and older in combination with miglustat. "Due to the way the data had been handled and the results analysed, there were uncertainties about the reliability and robustness of the results. Moreover, no benefit was seen in terms of ambulation and cognition," the EMA said.The agency noted that data for a subgroup of patients who were also taking miglustat showed a treatment effect favouring Meplyffa, though this "was not considered robust since effectiveness had not been demonstrated in the overall population."Zevra, whose shares tumbled nearly 24% on Friday, said it is going to request a re-examination of the CHMP opinion.The oral heat shock protein amplifier was approved by the FDA in 2024 under the brand Miplyffa, after a bumpy regulatory journey. That decision was based on data from a 50-patient, placebo-controlled Phase II/III study where patients who received thrice-daily Miplyffa had slower disease progression than those on placebo, as measured by the 4-domain NPC Clinical Severity Scale (R4DNPCCSS).

Evogene Ltd. (Nasdaq: EVGN; TASE: EVGN) and ELEO Inc., a private South Korean biotech based in Daejeon, announced a collaboration to discover oral small-molecule inhibitors of the PCSK9 pathway, pairing Evogene’s AI-driven computational chemistry platform with ELEO’s biological discovery work in lipid disease. The collaboration places Evogene among a growing group of companies pursuing orally administered PCSK9 inhibitors, a field that transitioned from an experimental concept to a commercially validated drug class with the recent FDA approval of Merck’s enlicitide. Developing orally available PCSK9 inhibitors has proven challenging because small molecules must disrupt the interaction between PCSK9 and the LDL receptor, a protein-protein interface traditionally considered difficult to target with conventional medicinal chemistry. Under the collaboration, Evogene’s contribution is its computational chemistry platform, which generates and prioritizes candidate structures in silico before wet-lab synthesis. ELEO is providing what the company describes as proprietary biological capabilities relevant to PCSK9 pathway suppression, though neither party has disclosed a specific lead series or nominated compound. No financial specifics were disclosed. The agreement fits a pattern Evogene has run repeatedly over the past year: it has struck a string of similar computational-chemistry tie-ups, including with Unravel Biosciences on demyelinating disease, with Professor Ehud Gazit and Tel Aviv University on metabolic disease, with Systasy and LMU University Hospital Munich on neutrophil-driven inflammation, and with Tel Aviv University’s Blavatnik Center for Drug Discovery on broader AI-driven small-molecule work. Evogene has also been layering AI agent capability into its ChemPass platform through an expanded Google Cloud partnership. The oral PCSK9 field has shifted rapidly from scientific ambition to commercial reality. In July 2026, Merck’s oral macrocyclic peptide PCSK9 inhibitor enlicitide received FDA approval for adults with hypercholesterolemia, becoming the first oral therapy targeting the pathway after demonstrating LDL-C reductions across the Phase III CORALreef program. AstraZeneca’s AZD0780, a conventional oral small molecule rather than a peptide, remains in clinical development following positive Phase IIb PURSUIT data, providing proof that small-molecule chemistry can also engage the historically challenging PCSK9 target. Established injectable therapies—including the monoclonal antibodies evolocumab and alirocumab, the siRNA inclisiran, and LIB Therapeutics’ lerodalcibep—continue to anchor the broader PCSK9 market. Against that backdrop, the Evogene-ELEO collaboration sits at the earliest stage of discovery, with no disclosed lead compound or clinical candidate. Rather than competing directly with established products, the partnership aims to determine whether AI-guided medicinal chemistry can identify differentiated oral small molecules capable of matching or improving on the efficacy, manufacturability or dosing profile of an increasingly crowded PCSK9 field. Access the AllSci platform to explore the science behind the news. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.