CHMP Meeting Highlights June 2023

This month, medicinal products for the following indications have received a positive opinion:

• Prophylaxis of migrain
• Symptomatic anaemia associated with chronic kidney diseas

New medicines recommended for approval:

Aquipta (atogepant): received a positive opinion for prophylaxis of migraine in adults who have at least 4 migraine days per month. Migraine is a chronic condition characterized by recurrent headaches that may affect quality of life and productivity. Although the causes of migraine are unknown, calcitonin gene-related peptides (CGRPs) have been found to be involved in the development of pain in migraine. Aquipta belongs to the CGRP receptor antagonists, also known as gepants.  Aquipta blocks the binding of CGRPs to their receptor, thereby preventing the development of the cascade of events that result in a migraine attack. For more information please consult the product for Aquipta on the EMA website.

Jesduvroq (daprodustat): received a positive opinion for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. Several factors can contribute to the development of anaemia in patients with CKD, including insufficient production of erythropoietin, impaired iron absorption, shorter lifespan of red blood cells or blood loss associated with haemodialysis. Jesduvroq inhibits the hypoxia-inducible factor (HIF) prolyl hydroxylase, thereby stabilizing HIFs’ alpha subunit (HIF-α). The HIF transcription factors subsequently induce the expression of erythropoietin. For more information please consult the product for Jesduvroq on the EMA website.

Recommendations on extensions of therapeutic indication:

Comirnaty Original/Omicron BA.4-5 (COVID-19 mRNA Vaccine [nucleoside modified]): extension of indication to include the active immunisation to prevent COVID-19 in individuals 6 months of age and older who have not previously received at least a primary vaccination course against COVID-19. Previously, Comirnaty Original/Omicron BA.4-5 was only authorised in patients who had previously received at least a primary vaccination course against COVID-19. The dose is different in the different age groups. For more information please consult the product for Comirnaty Original/Omicron BA.4-5 on the EMA website.

Imjudo (tremelimumab): extension of indication to the first-line treatment of adults with metastatic non-small cell lung cancer with no sensitising EGFR mutations or ALK positive mutations, in combination with durvalumab and platinum-based chemotherapy. Imjudo was already authorised for the treatment of hepatocellular carcinoma. For more information please consult the product for Imjudo on the EMA website.

Jardiance (empagliflozin): extension of indication to the treatment of chronic kidney disease in adults. Jardiance was already authorised for the treatment of type 2 diabetes mellitus and chronic heart failure. For more information please consult the product for Jardiance on the EMA website.

Lonsurf (trifluridine / tipiracil): extension of indication to the treatment, in combination with bevacizumab, of adult patients with metastatic colorectal cancer who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agent. Lonsurf was already authorised for the treatment of gastric cancer and colorectal cancer as monotherapy. For more information please consult the product for Lonsurf on the EMA website.

Mircera (methoxy polyethylene glycol-epoetin beta): extension of indication to include the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoietin stimulating agent (ESA) after their haemoglobin level was stabilised with the previous ESA. Mircera was already authorised in adults for the treatment of symptomatic anaemia associated with CKD. For more information please consult the product for Mircera on the EMA website.

Refixia (nonacog beta pegol): extension of indication to include the treatment and prophylaxis of bleeding in patients below 12 years of age with haemophilia B (congenital factor IX deficiency). Refixia was already authorised in patients 12 years of age and older. For more information please consult the product for Refixia on the EMA website.

Soliris (eculizumab): extension of indication to include the treatment of refractory generalized myasthenia gravis in patients aged 6 years and above who are anti-acetylcholine receptor (AChR) antibody-positive. Soliris was already authorised in this indication in adults. Furthermore, Soliris was already authorised for the treatment of paroxysmal nocturnal haemoglobinuria, atypical haemolytic uremic syndrome and neuromyelitis optica spectrum disorder. For more information please consult the product for Soliris on the EMA website.

Trodelvy (sacituzumab govitecan): extension of indication to the treatment as monotherapy of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting. Trodelvy was already authorised for the treatment of triple-negative breast cancer. 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:

Akeega (niraparib / abiraterone acetate): is indicated with prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA 1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated. EPAR Akeega.

Arexvy (Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E): is indicated for active immunisation for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in adults 60 years of age and older. EPAR Arexvy.

Bimervax (COVID-19 Vaccine [recombinant, adjuvanted]): is indicated as a booster for active immunisation to prevent COVID-19 in individuals 16 years of age and older who have previously received a mRNA COVID-19 vaccine. EPAR Bimervax.

Hyftor (sirolimus): is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis complex in adults and paediatric patients aged 6 years and older. EPAR Hyftor.

Omvoh (mirikizumab): is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment. EPAR Omvoh.

Pedmarqsi (sodium thiosulfate): is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours. EPAR Pedmarqsi.

Recently started procedures:

• Bimatoprost - Indicated for the reduction of intraocular pressure (IOP) in adults with open angle glaucoma or ocular hypertension who are unsuitable for topical IOP-lowering medications.
• COVID-19 vaccine - Immunisation to prevent COVID-19 caused by SARS-CoV-2.
• Danicopan - Orphan - Treatment of extravascular haemolysis in patients with paroxysmal nocturnal haemoglobinuria.
• Flortaucipir (18f) - Indicated for Positron Emission Tomography imaging of the brain.
• In vitro diagnostic medical device - Is indicated as an aid in the selection of adult hemophilia A patients for whom valoctocogene roxaparvovec treatment is being considered.
• Retifanlimab - Orphan - Treatment of Merkel cell carcinoma.
• Serplulimab - Orphan - First-line treatment of adult patients with extensive-stage small cell lung cancer.

Further inquiry note

basg_anfragen@basg.gv.at