EMA CHMP issued positive opinions for 12 medicines in July 2026. Explore four key recommendations, including Icotyde, Susvimo, Trixeo Aerosphere, and Enhertu plus pertuzumab, and their potential impact on treatment across dermatology, ophthalmology, respiratory medicine, and oncology.
Written By: Farha Farheen, PharmD,
Reviewed By: Pharmacally Editorial Team
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended 12 medicines for marketing authorization or label expansion during its July 2026 meeting. The recommendations include new medicines, additional therapeutic indications for established products, biosimilars, and generic medicines that now move to the European Commission for final regulatory review.
Among the month’s most notable decisions are two first-time EU marketing authorizations and two important indication expansions with the potential to influence clinical practice across multiple specialties. The highlighted recommendations include Icotyde (icotrokinra) for moderate-to-severe plaque psoriasis, Susvimo (ranibizumab) for neovascular age-related macular degeneration, Trixeo Aerosphere for maintenance treatment of asthma, and Enhertu (trastuzumab deruxtecan) plus pertuzumab as first-line therapy for HER2-positive metastatic breast cancer.
Icotyde Could Become the First Oral IL-23 Pathway Therapy for Plaque Psoriasis
CHMP recommended granting marketing authorization for Icotyde (icotrokinra) to treat adults and adolescents aged 12 years and older weighing at least 40 kg with moderate-to-severe plaque psoriasis.
Plaque psoriasis affects an estimated 1% to 4% of adults worldwide and continues to impose a substantial physical and psychological burden. Although several biologic therapies are available, many patients experience inadequate disease control, diminishing treatment response over time, or adverse effects.
Icotyde blocks the interleukin-23 (IL-23) receptor, reducing inflammatory signaling that drives psoriasis. If approved, it would become the first oral medicine targeting the IL-23 pathway in the European Union, complementing currently available injectable IL-23 inhibitors.
CHMP based its recommendation on data from four Phase III trials involving approximately 2,500 patients. Across three pivotal studies, 50% to 57% of patients receiving Icotyde achieved PASI 90 after 16 weeks compared with 1% to 4% receiving placebo. Additionally, 65% to 71% achieved an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin, versus 8% to 11% with placebo.
A fourth Phase III study evaluated patients with psoriasis affecting difficult-to-treat areas, including the scalp, genital region, hands, and feet.
Icotyde demonstrated a favorable safety profile, with fungal infections reported in 1.1% of patients as the most common adverse event.
CHMP Supports Susvimo as the First Continuous Drug Delivery Treatment for Wet AMD
CHMP also recommended approval of Susvimo (ranibizumab injection 100 mg/mL) delivered through Roche’s Contivue® refillable implant for patients with neovascular age-related macular degeneration.
Neovascular AMD is a leading cause of blindness among adults older than 60 years and affects approximately 1.7 million people across the European Union. Standard treatment typically requires frequent intravitreal anti-VEGF injections, creating a substantial treatment burden.
Susvimo continuously releases ranibizumab into the vitreous through a surgically implanted refillable reservoir. If approved, it would become the first and only continuous drug delivery treatment for nAMD in Europe and could reduce treatment frequency to two refill procedures per year.
The recommendation is supported by findings from the Phase III ARCHWAY, Phase II LADDER, and long-term PORTAL studies. Patients receiving Susvimo maintained vision outcomes comparable to monthly intravitreal ranibizumab injections, while long-term follow-up demonstrated maintained visual outcomes for up to seven years.
Approximately 95% of patients receiving scheduled twice-yearly refills required no supplemental anti-VEGF treatment, and the therapy remained generally well tolerated throughout long-term follow-up.
Trixeo Aerosphere Recommended for New Asthma Indication
CHMP recommended expanding the indication for Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate) to include maintenance treatment of asthma in patients aged 12 years and older who remain inadequately controlled on medium-dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) therapy.
The single-inhaler therapy combines an inhaled corticosteroid, a long-acting muscarinic antagonist (LAMA), and a long-acting beta2-agonist. It is already approved in Europe for chronic obstructive pulmonary disease (COPD). Approval would establish asthma as its second EU indication.
The recommendation is based on the replicate Phase III KALOS and LOGOS trials involving approximately 4,300 patients.
Compared with dual ICS/LABA therapy, Trixeo significantly improved lung function and reduced the annualized rate of severe asthma exacerbations in pooled analyses. Investigators also observed significant improvement in lung function within five minutes after the first dose, reflecting rapid bronchodilator activity.
No new safety or tolerability signals emerged during either study.
Professor Alberto Papi, Chair of Respiratory Medicine at the University of Ferrara and primary investigator, noted that many patients across Europe continue to experience uncontrolled asthma despite existing therapies. He said the CHMP recommendation could expand treatment options capable of improving disease control while reducing exacerbations.
Ruud Dobber, Executive Vice President of AstraZeneca’s BioPharmaceuticals Business Unit, said the recommendation builds on the recent US approval and reflects the company’s broader strategy to improve outcomes across both asthma and COPD.
Enhertu Plus Pertuzumab Advances Toward First-Line EU Approval for HER2-Positive Metastatic Breast Cancer
CHMP further recommended approval of Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer.
If approved, the regimen would become the first new first-line treatment option in the European Union for HER2-positive metastatic breast cancer in more than 10 years, replacing the long-standing taxane, trastuzumab, and pertuzumab (THP) standard of care.
The recommendation is supported by the Phase III DESTINY-Breast09 trial involving 1,157 patients.
Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% compared with THP (hazard ratio 0.56; p<0.00001). Median progression-free survival reached 40.7 months, compared with 26.9 months for THP, representing an improvement of more than one year. Clinical benefit remained consistent across key patient subgroups.
The combination demonstrated a safety profile consistent with the known safety profiles of each therapy, with no new safety concerns identified.
Susan Galbraith, Executive Vice President of Oncology Haematology R&D at AstraZeneca, said the findings establish a new benchmark for first-line treatment by extending median progression-free survival beyond three years.
John Tsai, Global Head of R&D at Daiichi Sankyo, added that the CHMP opinion moves the therapy closer to becoming an earlier treatment option for eligible patients across Europe.
Why These Four CHMP Recommendations Matter
Although 12 medicines received positive CHMP opinions during the July 2026 meeting, Icotyde, Susvimo, Trixeo Aerosphere, and Enhertu plus pertuzumab stand out for their potential to influence clinical practice across four major therapeutic areas.
Dermatology: Icotyde could become the first oral IL-23 pathway therapy in the European Union, expanding treatment options for patients with moderate-to-severe plaque psoriasis and offering an oral alternative to injectable biologics.
Ophthalmology: Susvimo introduces continuous anti-VEGF drug delivery through a refillable implant, with the potential to reduce treatment frequency and patient burden while maintaining long-term visual outcomes.
Respiratory Medicine: Trixeo Aerosphere expands single-inhaler triple therapy into asthma, providing an additional maintenance option for patients whose disease remains inadequately controlled on ICS/LABA therapy.
Oncology: Enhertu plus pertuzumab could redefine first-line treatment for HER2-positive metastatic breast cancer, supported by Phase III data demonstrating substantially longer progression-free survival than the current standard of care.
Together, these recommendations illustrate how regulatory innovation extends beyond the approval of new medicines to include meaningful indication expansions that could broaden treatment options across dermatology, ophthalmology, respiratory medicine, and oncology.
Path Forward
The CHMP’s positive opinions represent an important milestone in the European regulatory process but do not constitute final marketing authorization. The recommendations will now be reviewed by the European Commission, which is responsible for issuing legally binding decisions valid across all EU Member States.
If approved, Icotyde and Susvimo would enter the European market as new treatment options, while Trixeo Aerosphere and Enhertu plus pertuzumab would expand the clinical use of established medicines into new patient populations. Together, these recommendations highlight continued regulatory momentum in dermatology, ophthalmology, respiratory medicine, and oncology.
Reference
Trixeo recommended for approval in the EU by CHMP for the maintenance treatment of asthma