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This update contains 14 new monographs. Preparations have been updated for 4 countries.
New monographs:
• Anifrolumab is a human monoclonal antibody Type 1 interferon receptor antagonist used in the treatment of systemic lupus erythematosus.
• Asciminib, a BCR-ABL1 tyrosine kinase inhibitor specifically targeting the ABL myristoyl pocket (STAMP), is used for the treatment of chronic phase Philadelphia chromosome (Ph) positive chronic myeloid leukaemia (CML) including CML with a T315I mutation.
• Casirivimab is a recombinant human monoclonal antibody with antiviral activity against SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). It is used with imdevimab in the treatment and prevention of COVID-19 infection.
• Clascoterone is an androgen receptor inhibitor used topically for the treatment of acne vulgaris.
• Dostarlimab is a humanised immunoglobulin G4 monoclonal antibody that binds to PD-1. It is used for the treatment of solid tumours, including endometrial cancer, that are mismatch repair deficient (dMMR).
• Entrectinib is a protein kinase inhibitor that is used in the treatment of solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and ROS1-positive non-small cell lung cancer.
• Faricimab is a humanised immunoglobulin G1 monoclonal antibody that binds to and inhibits both vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2). It is used for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular oedema.
• Fostemsavir is a prodrug of temsavir, a HIV-1 entry inhibitor. It is used with other antiretrovirals for treatment of multidrug-resistant HIV-1 infection and AIDS in treatment-experienced patients.
• Imdevimab is a recombinant human monoclonal antibody with antiviral activity against SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). It is used with casirivimab in the treatment and prevention of COVID-19 infection.
• Margetuximab is a monoclonal antibody directed against cell surface proteins produced by the human epidermal growth factor receptor 2 (HER2) gene; it is used for the treatment of HER2-positive metastatic breast cancer.
• Mitapivat is a pyruvate kinase activator used in the treatment of haemolytic anaemia in patients with pyruvate kinase deficiency.
• Tazemetostat is a selective inhibitor of histone methyltransferase EZH2 (enhancer of zeste homolog 2) used for the treatment of epithelioid sarcoma and follicular lymphoma.
• Tebentafusp is a bispecific fusion protein that binds to both glycoprotein 100 on uveal melanoma cells and CD3 receptors on T-cells. It is used for the treatment of HLA-A*02:01-positive unresectable or metastatic uveal melanoma.
• Tralokinumab is a human monoclonal antibody that is used for the treatment of moderate to severe atopic eczema.
Updated names, synonyms and codes; official standards; official preparations:
• USP-NF 2022, Issue 2
• USP-NF 2022, Issue 3
Proprietary Preparations and Manufacturers updated for the following countries and
regions:
• Chile
• Mexico
• UK†
• USA†
† Countries updated on an ongoing basis
This update contains 17 new monographs. Preparations have been updated for 5 countries.
New monographs:
• Belzutifan is a hypoxia-inducible factor 2 alpha inhibitor. It is used for the treatment of tumours associated with von Hippel-Lindau disease, such as renal cell carcinoma, central nervous system haemangioblastomas, and pancreatic neuroendocrine tumours.
• Capmatinib is a tyrosine kinase inhibitor that targets mesenchymal-epithelial transition factor (MET). It is used in the treatment of metastatic non-small cell lung cancer with MET exon 14 skipping alterations.
• Efgartigimod alfa is a human immunoglobulin G1 (IgG1) antibody fragment that binds to the neonatal Fc receptor (FcRn). It is used as an adjunct to standard therapy in the treatment of generalised myasthenia gravis in patients who are anti-acetylcholine receptor (AChR) antibody-positive. Efgartigimod alfa is also being investigated in the treatment of primary immune thrombocytopenia, pemphigus, and chronic inflammatory demyelinating polyneuropathy.
• Evinacumab is a human monoclonal antibody which inhibits angiopoietin-like 3 (ANGPTL3) and is used with other low-density lipoprotein (LDL) cholesterol lowering therapies for the treatment of homozygous familial hypercholesterolaemia.
• Finerenone is a nonsteroidal selective mineralocorticoid receptor antagonist used in the treatment of chronic kidney disease associated with type 2 diabetes.
• Imlifidase is an IgG-cleaving immunosuppressant that is used in highly sensitised, positive crossmatch kidney transplant patients to enable transplantation.
• Infigratinib is a tyrosine kinase inhibitor that is used in the treatment of FGFR2-positive cholangiocarcinoma.
• Isatuximab is a monoclonal antibody directed against CD38 that is used in the treatment of relapsed or refractory multiple myeloma. It is also under investigation for the first-line treatment of multiple myeloma.
• Lemborexant is an orexin-receptor antagonist used in the management of insomnia.
• Lurbinectedin is an antineoplastic alkylating agent, used in the treatment of metastatic small cell lung cancer.
• Ripretinib is a tyrosine kinase inhibitor used in the treatment of advanced gastrointestinal stromal tumours.
• Sacituzumab govitecan is an antibody-drug conjugate consisting of a Trop-2-directed monoclonal antibody conjugated to SN-38, a topoisomerase I inhibitor and the active metabolite of irinotecan. It is used for the treatment of locally advanced or metastatic triple-negative breast cancer and urothelial cancer.
• Samidorphan is an opioid antagonist used in a combination preparation with olanzapine for the treatment of schizophrenia and bipolar disorder.
• Selpercatinib is a tyrosine kinase inhibitor that is used in the treatment of non-small cell lung cancer and thyroid cancers.
• Sotorasib is a KRAS inhibitor used for the treatment of locally advanced or metastatic KRASᴳ¹²ᶜ-mutated non-small cell lung cancer. It is also under investigation for the treatment of colorectal cancer and other solid tumours.
• Sutimlimab is a recombinant humanised monoclonal antibody that acts as a complement blocker by inhibiting the classical complement pathway at the C1s protein. It is used to reduce haemolysis in patients with cold haemagglutinin disease.
• Tafasitamab is a monoclonal antibody used in the treatment of diffuse large B-cell lymphoma (DLBCL).
Updated names, synonyms and codes; official standards; official preparations:
• BP 2021
• BP(Vet) 2021
• USP-NF 2022
Proprietary Preparations and Manufacturers updated for the following countries and regions:
• Canada
• France
• Germany
• Monaco
• Singapore
• Switzerland
• UK †
• USA †
† Countries updated on an ongoing basis
This update contains 11 new monographs. Preparations have been updated for 6 countries.
New monographs:
• Amivantamab is a recombinant human monoclonal antibody. It is used in the treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
• Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist that is used for the prevention of migraine.
• Avacopan is a complement 5a receptor (C5aR) antagonist that acts as a complement blocker by inhibiting C5a-mediated neutrophil activation and migration. It is used as an adjunct to standard therapy in the treatment of severe, active granulomatosis with polyangiitis (Wegener’s granulomatosis) and microscopic polyangiitis.
• Daridorexant is an orexin-receptor antagonist used as a hypnotic in the management of insomnia.
• Eptinezumab is a recombinant humanised monoclonal antibody that is a calcitonin gene-related peptide antagonist used for the prevention of migraine.
• Levamlodipine is the S-enantiomer of the calcium-channel blocker amlodipine and is used in the treatment of hypertension.
• Remimazolam is an ultra-short-acting benzodiazepine used for procedural sedation and for the induction and maintenance of general anaesthesia.
• Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. It is given for the prevention and treatment of migraine.
• Sotrovimab is a recombinant human monoclonal antibody with antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that is used in the treatment of mild to moderate COVID-19 infection in patients who do not require oxygen supplementation and are at increased risk of progressing to severe infection.
• Tepotinib is an orally-active tyrosine kinase inhibitor that targets mesenchymal-epithelial transition (MET) factor. It is used in the treatment of advanced non-small cell lung cancer with MET exon 14 skipping alterations.
• Vericiguat is a guanylate cyclase stimulator used in the treatment of heart failure with reduced ejection fraction.
Updated names, synonyms and codes; official standards; official preparations:
• USP NF 2021, Issue 3
• PhEur 10.6
• PhEur 10.5
• PhEur 10.4
• ATC codes: Encorafenib, Inotuzumab ozogamicin, Osimertinib, Ribociclib
Proprietary Preparations and Manufacturers updated for the following countries and regions:
• Japan
• Poland
• Spain
• Sweden
• UK†
• USA†
† Countries updated on an ongoing basis
This update contains 9 new monographs and 1 existing monograph has been updated. Preparations have been updated for 3 countries.
New monographs:
• Abrocitinib is a Janus kinase inhibitor that is used in the treatment of atopic eczema.
• Levoketoconazole is the 2S,4R-enantiomer of ketoconazole, a potent inhibitor of cortisol synthesis. It is used in the treatment of endogenous Cushing’s syndrome when surgery is not an option or has not been curative.
• Maribavir is an orally active benzimidazole riboside antiviral drug used for the treatment of post-transplant CMV infection refractory to standard antiviral drugs.
• Molnupiravir is an oral prodrug with antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that is used in the treatment of mild to moderate COVID-19 (coronavirus disease 2019) infection.
• Nirmatrelvir is an inhibitor of coronavirus 3C-like protease that is used in the treatment of COVID-19 infection in patients who do not require oxygen supplementation and are at increased risk of progressing to severe infection.
• Ponesimod is an immunomodulator used in the treatment of relapsing forms of multiple sclerosis, including relapsing-remitting disease and active secondary progressive disease, and in clinically isolated syndrome.
• Tezepelumab is a recombinant human monoclonal antibody that binds to and inhibits thymic stromal lymphopoietin. It is used in the management of severe asthma.
• Tucatinib is an orally active tyrosine kinase inhibitor of the human epidermal growth factor receptor 2 (HER2). It is used with trastuzumab and capecitabine in the treatment of HER2-positive locally advanced or metastatic breast cancer.
• Ubrogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist that is used in the acute treatment of migraine.
Notable revisions:
• Tofacitinib: major adverse cardiovascular events, including myocardial infarction, stroke, and cardiovascular death, have been reported in patients taking Janus kinase (JAK) inhibitors.
Updated names, synonyms and codes; official standards; official preparations:
• Ph Eur 10.1, 10.2, and 10.3
• USP-NF 2021 Issue 2
Proprietary Preparations and Manufacturers updated for the following countries and regions:
• Italy
• UK†
• USA†
† Countries updated on an ongoing basis
This update contains 3 new monographs. Preparations have been updated for 6 countries.
New monographs:
• Pafolacianine is a fluorescent optical imaging agent used as an adjunct for intra-operative visualisation of malignant lesions during surgery for ovarian cancer.
• Vosoritide is a modified recombinant C-type natriuretic peptide (CNP) analogue used in the treatment of achondroplasia in children with open epiphyses.
• Odevixibat is a locally-acting ileal bile acid transporter inhibitor used in the treatment of pruritus in patients with progressive familial intrahepatic cholestasis.
Updated names, synonyms and codes; official standards; official preparations:
• Entries for USP-NF have been updated for USP-NF 2021
Proprietary Preparations and Manufacturers updated for the following countries and regions:
• Austria
• China
• Denmark
• Israel
• UK†
• USA†
† Countries updated on an ongoing basis
This update contains 5 new monographs. Preparations have been updated for 2 countries.
New monographs:
• Avapritinib is a tyrosine kinase inhibitor used in the treatment of gastrointestinal stromal tumours and systemic mastocytosis.
• Difelikefalin is a kappa-opioid receptor agonist used in the management of moderate to severe pruritus associated with chronic kidney disease in haemodialysis patients.
• Inclisiran is a double-stranded, small interfering ribonucleic acid (siRNA) conjugate used in the management of heterozygous familial and non-familial hypercholesterolaemia and mixed dyslipidaemia.
• Ozanimod is an immunomodulator used in the treatment of relapsing forms of multiple sclerosis and ulcerative colitis.
• Upadacitinib is an orally active Janus kinase inhibitor used in the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and atopic eczema.
Updated names, synonyms and codes; official standards; official preparations:
• Entries for the European Pharmacopoeia have been updated for Ph Eur 10
Proprietary Preparations and Manufacturers updated for the following countries and regions:
• UK†
• USA†
† Countries updated on an ongoing basis
