CHMP Meeting Highlights January 2022
In the month of January 2022, medicinal products for the following indications have received a positive opinion:
- COVID-19
- Diffuse large B-cell lymphoma
- Follicular lymphoma grade 3B
- Primary mediastinal large B-cell lymphoma
New medicines recommended for approval
Breyanzi (lisocabtagene maraleucel) received a positive opinion based on an assessment by EMA’s Committee for Advanced Therapies (CAT) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic therapy. DLBCL, PMBCL and FL3B are subtypes of large B-cell lymphomas, and represent approximately 80 %, 3 % and 1 % of all non-Hodgkin lymphomas, respectively. These types of lymphomas can be classified as indolent or aggressive. The latter can be fatal within a short period of time.
Breyanzi consists of modified autologous T cells. Remarkably, the single WHO INN “lisocabtagene maraleucel” includes two “active substances”, CD8+ and CD4+ T cells (lentiviral-transduced anti CD19), which trigger the cytolytic death of B-lineage cells expressing the antigen CD19. Breyanzi is considered an advanced therapy medicinal product (ATMP). For more information, visit the EMA press release on Breyanzi.
Paxlovid (Nirmatrelvir / ritonavir) received a positive opinion for a conditional marketing authorisation (CMA). It is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19. COVID-19 is a contagious disease caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Nirmatrelvir, or PF-07321332, is an antiviral drug that inhibits the 3C-like protease, the main protease found in coronaviruses. Nirmatrelvir has shown antiviral effects against several variants of SARS-CoV-2, including the Omicron variant. Ritonavir is co-administered as an enhancer of nirmatrelvir, since it inhibits its metabolism, resulting in increased plasma concentrations. For more information, visit the EMA press release on Paxlovid or the EMA website on Paxlovid.
Recommendations on extensions of therapeutic indication
Ayvakyt (avapritinib) extension of indication as monotherapy to include the treatment of adult patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated haematological neoplasm or mast cell leukaemia, after at least one systemic therapy. Avapritinib is a tyrosine kinase inhibitor targeting c-KIT also known as CD117 or mast/stem cell growth factor receptor. Ayvakyt has been authorised previously for the treatment of gastrointestinal stromal tumour.
Briviact (brivaracetam): extension of indication to include the treatment of patients from 2 years 4 years of age with epilepsy.
Dupixent (dupilumab): extension of indication as add-on maintenance treatment of children 6 to 11 years old with severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide and inadequately controlled with medium to high dose inhaled corticosteroids plus another medicinal product for maintenance treatment. Dupixent has previously been approved for this in indication in adults and adolescents 12 years and older. Dupixent is already approved for the treatment of atopic dermatitis and chronic rhinosinusitis with nasal polyposis.
Jardiance (empagliflozin): update of the indication to include the treatment of adults with symptomatic chronic heart failure. Jardiance is already approved for the treatment of type 2 diabetes mellitus.
Senshio (ospemifene): update of the indication to include the treatment of moderate to severe symptomatic vulvar and vaginal atrophy in post-menopausal women.
Tecfidera (dimethyl fumarate): extension of the indication to include the treatment of paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis. Tecfidera is already approved for this indication in adults.
Vimpat (lacosamide): extension of indication to include paediatric patients from 2 to 4 years of age with epilepsy. Vimpat is already approved for this indication in adults, adolescents and children from 4 years of age.
Newly published European Public Assessment Reports (EPAR)
The European Public Assessment Report (EPAR) is the main document where the European Medicines Agency (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:
Artesunate Amivas (artesunate) is indicated for the initial treatment of severe malaria in adults and children. EPAR Artesunate Amivas.
Nuvaxovid [COVID-19 Vaccine (recombinant, adjuvanted)] is indicated for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older. EPAR Nuvaxovid.
Tecovirimat SIGA (tecovirimat monohydrate) is indicated for the treatment of smallpox, monkeypox and cowpox in adults and children with body weight at least 13 kg. It is also indicated for the treatment of complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg. EPAR Tecovirimat SIGA.
Xevudy (sotrovimab) is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19. EPAR Xevudy.
Recently started procedures
Every month, new marketing authorization applications are submitted to EMA under the centralized authorization procedure. The CHMP carries out a scientific assessment of the applications and gives a recommendation. The CHMP has started the assessment of the following submitted applications:
Initial marketing authorization applications:
- Bardoxolone methyl / bardoxolone methyl - Orphan - Treatment of chronic kidney disease.
- Deucravacitinib - Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
- Ganaxolone - Orphan - Treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 deficiency disorder.
- Gozetotide - Indicated for the identification of prostate-specific membrane antigen (PSMA)-positive lesions after radiolabelling with gallium-68.
- Loncastuximab tesirine - Orphan - Treatment of adult patients with relapsed or refractory large B-cell lymphoma.
- Lutetium (177lu) vipivotide tetraxetan - Treatment of PSMA-positive metastatic castration-resistant prostate cancer.
- Mosunetuzumab - Treatment of refractory follicular lymphoma.
- Ruxolitinib - Treatment of non-segmental vitiligo.
- Spesolimab - Treatment of flares in adult patients with generalised pustular psoriasis.
- Sutimlimab - Orphan - Treatment of haemolysis in adult patients with cold agglutinin disease.
- Tirzepatide - Treatment of adults with type 2 diabetes mellitus.
Other topics of interest
Referral procedure under Article 29(4) for Nasolam (midazolam):
The CHMP completed a review of Nasolam (midazolam, nasal spray) following a disagreement among EU Member States regarding its authorisation. The committee concluded that the benefits of this medicine outweigh its risks, and that marketing authorisations should be granted in those Member States of the EU where the company has applied for marketing authorisation. More information can be found here: Nasolam.