CHMP Meeting Highlights March 2023

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

• Multiple sclerosis
• Prevention of COVID-19
• Prevention of ototoxicity induced by cisplatin chemotherapy
• Ulcerative colitis

New medicines recommended for approval:

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 an mRNA COVID-19 vaccine.

COVID-19 or Coronavirus disease 2019, is a contagious disease caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although this virus can infect a wide variety of cells, it is most known for causing respiratory tract symptoms, which vary from mild to severe. The virus enters the cells mainly by binding to the angiotensin converting enzyme 2 (ACE2). Bimervax is a vaccine harbouring a recombinant modified Spike protein antigen. The Spike protein is the major viral surface protein and it mediates viral entry by binding to ACE2 on the host cell. Bimervax is the eighth vaccine recommended in the European Union for protecting against COVID-19. However, it has only received a positive opinion as a booster and not for primary vaccination. For more information visit the EMA news announcement on Bimervax. For more information please consult the product for Bimervax on the EMA website.

Briumvi (ublituximab): is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features.

Multiple sclerosis is a chronic neurodegenerative autoimmune disease of the central nervous system, which leads to irreversible decrease in physical and cognitive function. Briumvi is an immunosuppressant monoclonal antibody, which binds to the CD20 surface antigen of B-cells, leading to antibody-dependent cell death. For more information please consult the product for Briumvi on the EMA website.
 
Omvoh (mirikizumab): is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
UC is a chronic inflammatory disease that affects the colon. Although the aetiology is not fully understood, many factors seem to be involved in the pathogenesis of the disease, including altered immune responses, environmental and genetics factors. Omvoh is a monoclonal antibody that binds to interleukin 23 (IL-23), a pro-inflammatory cytokine involved in promoting inflammation in UC, and inhibits its binding to the IL23 receptor, thereby disrupting the cytokine signalling cascade. For more information please consult the product for Omvoh on the EMA website.

Pedmarqsi (sodium thiosulfate): received a positive opinion for a paediatric-use marketing authorisation (PUMA) 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. Cisplatin is a platinum-based chemotherapeutic agent widely used for the treatment of solid tumours. However, the development of ototoxicity is a serious hindrance of effective treatment. Although the mechanism for this toxicity has not been fully elucidated, it is accepted that the excessive production of reactive oxygen species (ROS) plays a major role in the development of platinum-induced hearing loss. Pedmarqsi is an otoprotectant with free-radical scavenging potential, which directly reduced ROS. Furthermore, it can bind to platinum, producing a biologically-inactive complex. For more information please consult the product for Pedmarqsi on the EMA website.   

Recommendations on extensions of therapeutic indication:

Breyanzi (lisocabtagene maraleucel): extension of indication to the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. Breyanzi was already authorised for the treatment of relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy. For more information please consult the product for Breyanzi on the EMA website.

Entresto and Neparvis (sacubitril / valsartan): extension of indication to include the treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction in children and adolescents aged one year or older. Entresto and Neparvis were already authorised in adults. For more information please consult the product for Neparvis and Entresto on the EMA website.

Tenkasi (oritavancin): extension of indication to the treatment of acute bacterial skin and skin structure infections in paediatric patients aged 3 months and older. Tenkasi was already authorised in adults. For more information please consult the product for Tenkasi on the EMA website.

Ultomiris (ravulizumab): extension of indication to the treatment of adult patients with neuromyelitis optica spectrum disorder who are anti-aquaporin 4 (AQP4) antibody-positive. Ultomiris was already authorised for the treatment of paroxysmal nocturnal haemoglobinuria, atypical haemolytic uremic syndrome and generalized myasthenia gravis. For more information please consult the product for Ultomiris on the EMA website.

Wegovy (semaglutide): Extension of indication, as an adjunct to a reduced-calorie diet and increased physical activity, for weight management in adolescents ages 12 years and above with obesity and body weight above 60 kg. Wegovy was already authorised in adults. For more information please consult the product for Wegovy 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:

Imjudo (tremelimumab): in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma. Siehe EPAR Imjudo.

Sotyktu (deucravacitinib): is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Siehe EPAR Sotyktu.

Tremeliumab AstraZeneca (tremelimumab): in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer with no sensitising EGFR mutations or ALK positive mutations. Siehe EPAR Tremelimumab AstraZeneca.

Recently started procedures:

• Aumolertinib - Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer.
• Dopamine hydrochloride - PUMA - Treatment of hypotension in neonates, infants and children.
• Etrasimod - Treatment of patients with moderately to severely active ulcerative colitis.
• In vitro diagnostic medical device - To detect internal tandem duplication and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
• Momelotinib - Orphan - Treatment of disease-related splenomegaly or symptoms and anaemia.
• Rozanolixizumab - Orphan - Treatment of generalised myasthenia gravis.
• Teriparatide - Orphan - Parathormone replacement therapy indicated for the treatment of hypoparathyroidism in adults.
• Tofersen - Treatment of adults with amyotrophic lateral sclerosis associated with a mutation in the superoxide dismutase 1 gene.
• Toripalimab - Combination treatment for metastatic or recurrent locally advanced nasopharyngeal carcinoma and for metastatic or recurrent oesophageal squamous cell carcinoma.

Further inquiry note

basg_anfragen@basg.gv.at