CHMP Meeting Highlights November 2022
This month, medicinal products for the following indications have received a positive opinion:
- Prevention of COVID-19
New medicines recommended for approval:
VidPrevtyn Beta (COVID-19 vaccine [recombinant, adjuvanted]) is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received an mRNA or adenoviral vector 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). VidPrevtyn Beta 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. VidPrevtyn Beta is the seventh 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 VidPrevtyn Beta. For more information please consult the product for VidPrevtyn Beta on the EMA website.
Recommendations on extensions of therapeutic indication:
Ceprotin (human protein C): The indication has been updated as follows: for prophylaxis and treatment of purpura fulminans, coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein C deficiency. Importantly, venous thrombotic events has been newly added to the extended indication. For more information please consult the product for Ceprotin on the EMA website.
DuoPlavin (clopidogrel / acetylsalicylic acid): Extension of indication as continuation therapy in ST segment elevation acute myocardial infarction in patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic / fibrinolytic therapy. DuoPlavin was already authorised as continuation therapy in non-ST segment elevation acute coronary syndrome. For more information please consult the product for DuoPlavin on the EMA website.
Dupixent (dupilumab): Extension of indication to include the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Dupixent was already authorised for the treatment of atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis. For more information please consult the product for Dupixent on the EMA website.
Enhertu (trastuzumab deruxtecan): Extension of indication to include the treatment, as monotherapy, of adult patients with advanced Human Epidermal Growth Factor Receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. Enhertu was already authorised for the treatment of breast cancer. For more information please consult the product for Enhertu on the EMA website.
Eylea (aflibercept): Extension of indication to include the treatment of preterm infants with retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+) or aggressive posterior ROP disease. Eylea was already authorised for the treatment of adults with neovascular (wet) age-related macular degeneration and visual impairment due to diabetic macular oedema, myopic choroidal neovascularisation or macular oedema secondary to retinal vein occlusion. For more information please consult the product for Eylea on the EMA website.
Imfinzi (durvalumab): Extension of indication to include the first-line treatment of adults with unresectable or metastatic biliary tract cancer, in combination with gemcitabine and cisplatin. Imfinzi was previously authorised for the treatment of non-small cell lung cancer and extensive-stage small cell lung cancer. For more information please consult the product for Imfinzi on the EMA website.
Iscover (clopidogrel): Extension of indication to include ST segment elevation acute myocardial infarction, in combination with acetylsalicylic acid in patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or in medically treated patients eligible for thrombolytic/fibrinolytic therapy. Iscover was already authorised for myocardial infarction or established peripheral arterial disease and non-ST segment elevation acute coronary syndrome. For more information please consult the product for Iscover on the EMA website.
Lynparza (olaparib): Extension of indication to include the treatment in combination with abiraterone and prednisone or prednisolone of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. Lynparza was already authorised for the treatment of mCRPC (as monotherapy), ovarian cancer, breast cancer and adenocarcinoma of the pancreas. For more information please consult the product for Lynparza on the EMA website.
Plavix (clopidogrel): Extension of indication to include ST segment elevation acute myocardial infarction, in combination with acetylsalicylic acid in patients undergoing percutaneous coronary intervention (including patients undergoing a stent placement) or in medically treated patients eligible for thrombolytic/fibrinolytic therapy. Plavix was already authorised for myocardial infarction or established peripheral arterial disease and non-ST segment elevation acute coronary syndrome. For more information please consult the product for Plavix on the EMA website.
Xofluza (baloxavir marboxil): Extension of indication to include the treatment and post-exposure prophylaxis of influenza in paediatric patients from 1 year of age. Xofluza was already authorised in this indication in patients over 12 years of age. For more information please consult the product for Xofluza on the EMA website.
Recently started procedures:
- Alpelisib - Orphan - Treatment of patients with severe manifestations of Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Catalytic Subunit Alpha (PIK3CA)-related overgrowth spectrum.
- Atogepant monohydrate - Prophylaxis of migraine in adults who have at least 4 migraine days per month.
- Dantrolene sodium, hemiheptahydrate - Orphan - Treatment of malignant hyperthermia (including suspected cases).
- In vitro medical device - Human albumin solution / gentamicin sulfate - Human assisted reproductive techniques including in vitro fertilisation procedures.
- In vitro diagnostic medical device - In vitro qualitative immunohistochemical detection of programmed death-ligand 1 (PD-L1).
- Ivosidenib - Orphan - Treatment of acute myeloid leukaemia.
- Piflufolastat (18f) - Imaging in patients undergoing oncologic diagnostic procedures when increased expression of prostate specific membrane antigen is a diagnostic target.
- Trastuzumab duocarmazine - Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-positive metastatic breast cancer.
Other topics of interest
Update on the following authorised medicines for the prevention of COVID-19:
The CHMP has recommended extending the indication of COVID-19 vaccine Comirnaty targeting the original strain and Omicron subvariants BA.4 and BA.5 to children between 5 to 11 years of age.
The extension of indication is as follows:
Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children 5 to 11 years of age who have previously received at least a primary vaccination course against COVID-19.
Previous CHMP Meeting Highlights can be accessed at: https://www.basg.gv.at/en/healthcare-professionals/chmp-highlights
