CHMP Meeting Highlights July 2026 New
This month, medicinal products for the following indications have received a positive opinion:
- primary hypercholesterolaemia
- plaque psoriasis
- primary biliary cholangitis
- Cerebral Adrenoleukodystrophy
- neovascular age‑related macular degeneration
- COVID-19
New medicines recommended for approval:
Evlarco (obicetrapib / ezetimibe): has received a positive opinion for the treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- in combination with a statin in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin in addition to ezetimibe or,
- alone in patients who are either statin-intolerant or for whom a statin is contraindicated and are unable to reach LDL-C goals with ezetimibe alone or,
- in patients already being treated with the combination of obicetrapib and ezetimibe as separate tablets with or without statin.
Primary hypercholesterolaemia is a genetic disorder that causes abnormally high levels of low‑density lipoprotein (LDL) cholesterol in the blood, usually due to mutations affecting LDL receptors or related proteins. Mixed dyslipidaemia is a lipid disorder characterised by elevated LDL-cholesterol and triglycerides, usually accompanied by reduced high‑density lipoprotein (HDL).
Evlarco is a fixed-dose combination of obicetrapib and ezetimibe. Obicetrapib is a selective inhibitor of the cholesteryl ester transfer protein (CETP). Ezetimibe is an inhibitor NPC1L1 a intestinal transport protein for cholesterol. For more information please consult the product for Evlarco on the EMA website.
Icotyde (icotrokinra hydrochloride): has received a positive opinion for the treatment of moderate to severe plaque psoriasis in adults, and adolescents 12 years of age and older and weighing at least 40 kg, who are candidates for systemic therapy.
Psoriasis is a common chronic inflammatory skin disease with different clinical phenotypes with 80 to 90 % of patients being affected by plaque psoriasis. Raised, sharply demarcated, erythematous plaques covered by silvery scales characterize plaque psoriasis. Icotyde is an antagonist of the interleukin-23 receptor. IL-23 is a proinflammatory cytokine. A news announcement was released by the EMA for this product. For more information please consult the product for Icotyde on the EMA website.
Lynavoy (linerixibat): has received a positive opinion for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis (PBC).
PBC is an autoimmune disease of the liver causing the slow destruction of the small bile ducts. This leads to cholestasis and damages the liver further. Cholestatic pruritus is a symptom of PBC and characterized by a severe, generalized or localized itch caused by reduced or blocked bile flow from the liver. Lynavoy is an inhibitor of the ileal bile acid transporter (IBAT) that decreases the reabsorption of bile acids from the gut, thereby improving cholestatic pruritus. An orphan designation was granted for the treatment of this disease. For more information please consult the product for Lynavoy on the EMA website.
Lyrokaul (lerodalcibep): has received a positive opinion for the treatment of adults with primary hypercholesterolaemia (heterozygous familial (HeFH) and non-familial) or mixed dyslipidaemia as an adjunct to diet:
- in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin, or
- alone or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated.
Primary hypercholesterolaemia is a genetic disorder that causes abnormally high levels of low‑density lipoprotein (LDL) cholesterol in the blood, usually due to mutations affecting LDL receptors or related proteins. Mixed dyslipidaemia is a lipid disorder characterised by elevated LDL-cholesterol and triglycerides, usually accompanied by reduced high‑density lipoprotein (HDL). Lyrokaul is a fusion protein that binds the proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 regulates the Low-Density-Lipoprotein-Receptor (LDLR). By binding PCSK9 more LDLR is available and promotes the uptake of LDL into the cells, thus lowering LDL in the blood. For more information please consult the product for Lyrokaul on the EMA website.
Nezglyal (leriglitazone): has received a positive opinion for the marketing authorisation under exceptional circumstances for the treatment of Cerebral Adrenoleukodystrophy (cALD) in males with Adrenoleukodystrophy (ALD) aged 2 to 12 years with non-Gadolinium (Gd) enhancing lesions (i.e. Gd negative) in brain Magnetic Resonance Imaging (MRI), with a Neurological Functional Score (NFS) of 0 or 1.
cALD is an X‑linked peroxisomal disorder caused by ABCD1 mutations that prevent transport and degradation of very‑long‑chain fatty acids, resulting in their toxic accumulation in the brain and adrenal cortex. In boys, the cerebral form typically appears in late childhood or adolescence with rapid neuropsychiatric decline, motor deficits, vision loss, and adrenal insufficiency, often leading to death within a few years if untreated. Nezglyal is a selective peroxisome proliferator-activated receptor gamma (PPARγ) agonist. It has a neuroprotective activity in the central nervous system reducing neuroinflammation and improving the integrity of the blood-brain-barrier. An orphan designation was granted for the treatment of this disease. For more information please consult the product for Nezglyal on the EMA website.
Susvimo (ranibizumab): has received a positive opinion for the treatment of neovascular (wet) age‑related macular degeneration (nAMD) who have achieved stable disease after previously responding to intravitreal treatment with a vascular endothelial growth factor (VEGF) inhibitor medicinal product.
Vascular endothelial growth factor (VEGF) is the main protein responsible for the induction of blood vessel growth and, therefore, it is thought contribute to the pathophysiology of retinal vascular diseases, such as nAMD. Susvimo is a monoclonal antibody that targets VEGF, thereby blocking the binding to its receptor on endothelial cells, and preventing the growth of new abnormal blood vessels in the back of the eye. A news announcement was released by the EMA for this product. For more information please consult the product for Susvimo on the EMA website.
Ubeslo (obicetrapib): has received a positive opinion for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia, as an adjunct to diet:
- in combination with a statin or statin with other lipid‑lowering therapies in patients unable to reach low‑density lipoprotein cholesterol (LDL‑C) goals with the maximum tolerated dose of a statin or,
- alone or in combination with other lipid-lowering therapies in patients who are statin‑intolerant, or for whom a statin is contraindicated.
Primary hypercholesterolaemia is a genetic disorder that causes abnormally high levels of low‑density lipoprotein (LDL) cholesterol in the blood, usually due to mutations affecting LDL receptors or related proteins. Mixed dyslipidaemia is a lipid disorder characterised by elevated LDL-cholesterol and triglycerides, usually accompanied by reduced high‑density lipoprotein (HDL). For more information please consult the product for Ubeslo on the EMA website.
Zokovea (ensitrelvir): has received a positive opinion for the post‑exposure prophylaxis of COVID‑19 in adults and adolescents aged 12 years and older. Zokovea should be used in accordance with official recommendations. Zokovea is a selective inhibitor of the 3C-like protease of SARS-CoV-2. By inhibiting this protease the virus replication is stopped.For more information please consult the product for Zokovea on the EMA website.
Recommendations on extensions of therapeutic indication:
Enhertu (trastuzumab deruxtecan): extension of indication for Entertu in combination with pertuzumab to include the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. Enhertu is already authorised for the treatment of metastatic breast cancer in different settings and line of treatment. For more information please consult the product for Enhertu on the EMA website.
Jivi (damoctocog alfa pegol): extension of indication for Jivi to include the treatment and prophylaxis of bleeding in patients ≥ 7 years of age with haemophilia A (congenital factor VIII deficiency). Previously Jivi was only authorised for patients that were already treated for haemophilia A. For more information please consult the product for Jivi on the EMA website.
Piqray (alpelisib): extension of indication for Piqray to include in combination with fulvestrant the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following an endocrine-based regimen. Previously the indication was restricted to patients who progressed after an endocrine monotherapy. For more information please consult the product for Piqray on the EMA website.
Repatha (evolocumab): extension of indication for Repatha to include the treatment of adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL‑C levels, as an adjunct to correction of other risk factors:
- in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Previously Repatha was rescripted to patients with established atherosclerotic cardiovascular disease. For more information please consult the product for Repatha on the EMA website.
Rinvoq (upadacitinib): extension of indication for Rinvoq to include the treatment of active polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), in patients 2 years of age and older who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate. Rinvoq is already authorised for the treatment of different types of arthritis. For more information please consult the product for Rinvoq on the EMA website.
Riltrava Aerosphere / Trixeo Aerosphere (formoterol / glycopyrronium bromide / budesonide): extension of indication for Riltrava Aerosphere/Trixeo Aerosphere to include the maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid and a long-acting beta2-agonist. Both products are already authorised for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD). For more information please consult the product for Riltrava Aerosphere / Trixeo Aerosphere on the EMA website.
Trodelvy (sacituzumab govitecan): extension of indication for Trodelvy to include in combination with pembrolizumab the treatment of dult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10. Trodelvy is already authorised for the treatment triple-negative breast cancer in different settings and line of treatment. For more information please consult the product for Trodelvy on the EMA website.
Newly published EPARs:
The EPAR (European public assessment report) is the main document where the EMA publishes detailed information on the medicines assessed by the CHMP. Below is a list of the EPARs for recently approved products that have been made available on the EMA homepage:
Redemplo: is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with familial chylomicronaemia syndrome (FCS).
Jascayd: is indicated for the treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF). Jascayd is indicated for the treatment of adult patients with Progressive Pulmonary Fibrosis (PPF).
Previous CHMP Meeting Highlights can be accessed at: https://www.basg.gv.at/en/healthcare-professionals/chmp-meeting-highlights-basg
