CHMP Meeting Highlights January 2023

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

• Plaque psoriasis

New medicines recommended for approval:

Sotyktu (deucravacitinib): is indicated for the treatment of moderate to severe plaque psoriasis in adults 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. Sotyktu is a small molecule highly selective inhibitor of the tyrosine kinase 2 (TYK2), a member of the Janus kinase (JAK) protein family, a family of kinases involved in cytokine signalling. By inhibiting TYK2, Sotyktu reduces inflammatory cascade reactions. For more information please consult the product for Hemgenix on the EMA website.

Recommendations on extensions of therapeutic indication:

Byfavo (remimazolam): extension of indication to the induction and maintenance of general anesthesia in adults. Byfavo was already authorised for procedural sedation in adults. For more information please consult the product for Byfavo on the EMA website.

Dupixent (dupilumab): extension of indication to the treatment of severe atopic dermatitis (AD) in children 6 months to 11 years old who are candidates for systemic therapy. Dupixent was already authorised in children 6 to 11 years old in this setting and in adults and adolescents older than 12 year for the treatment of moderate-to-severe AD. Furthermore, Dupixent was already authorised for the treatment of asthma, chronic rhinosinusitis with nasal polyposis and prurigo nodularis. For more information please consult the product for Dupixent on the EMA website.

Nubeqa (darolutamide): extension of indication to the treatment of adult men with metastatic hormone sensitive prostate cancer in combination with docetaxel and androgen deprivation therapy. Nubeqa was already authorised for the treatment of non-metastatic castration resistant prostate cancer. For more information please consult the product for Nubeqa on the EMA website.

Reblozyl (luspatercept): extension of indication to the treatment of anaemia associated with non-transfusion-dependent beta-thalassaemia in adults. Reblozyl was already authorised for the treatment of anaemia associated with transfusion-dependent beta-thalassaemia. For more information please consult the product for Reblozyl on the EMA website.

Trecondi (treosulfan): extension of indication to include the conditioning treatment prior to allogeneic haematopoietic stem cell transplantation in paediatric patients older than one month with non-malignant diseases, in combination with fludarabine. Trecondi was already authorised for conditioning treatment in adults with malignant and non-malignant diseases and in paediatric patients with malignant diseases. For more information please consult the product for Trecondi on the EMA website.

Trulicity (dulaglutide): extension of indication to the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
• in addition to other medicinal products for the treatment of diabetes.

Trulicity was already authorised in adults in this indication. For more information please consult the product for Trulicity on the EMA website.

Wakix (pitolisant): extension of indication to the treatment of narcolepsy with or without cataplexy in adolescents and children from the age of 6 years. Wakix was already authorised in adults in this indication. For more information please consult the product for Wakix 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:

Ebvallo (tabelecleucel): is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.  Ebvallo is an advanced therapy medicinal product (ATMP) composed of allogeneic T-cells, selected for their specific immunological function (lysis of EBV+ targets) and sufficient human leukocyte antigen (HLA) similarity between donor and recipient. Although limited to a niche indication, the use of allogenic T-cells is a new, previously unauthorized mode of action for the immunotherapy of cancer. EPAR Ebvallo.

Eladynos (abaloparatide): is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. EPAR Eladynos.

Locametz (gozetotide): after radiolabelling with gallium-68, is indicated for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with positron emission tomography in adults with prostate cancer (PCa) in the following clinical settings:
•    Primary staging of patients with high-risk PCa prior to primary curative therapy,
•    Suspected PCa recurrence in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy,
•    Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated. EPAR Locametz.

Mycapssa (octreotide): is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues. EPAR Mycapssa.

Pluvicto [lutetium-177 vipivotide tetraxetan]: in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition is indicated for the treatment of adult patients with progressive PSMA-positive mCRPC who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. While PSMA has been used in the diagnostic of prostate cancer for several years, Pluvicto is the first cancer treatment targeting PSMA that received a positive CHMP opinion. EPAR Pluvicto.

Zynlonta (loncastuximab tesirine): as monotherapy, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma, after two or more lines of systemic therapy. EPAR Zynlonta.

Recently started procedures:

• Dabrafenib - Orphan - Treatment of glioma.
• Trametinib - Orphan - Treatment of glioma.
• Fezolinetant - Treatment of moderate to severe vasomotor symptoms associated with menopause.
• Latanoprost - Reduction of elevated intraocular pressure.
• Zilucoplan - Orphan - treatment of generalised myasthenia gravis in adults.

Further inquiry note

basg_anfragen@basg.gv.at