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Reviewed and updated every 3 months by expert teams
*based on average data in the last 12 months
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
This update contains 3 new monographs. Preparations have been updated for 7 countries.
New monographs:
• Bempedoic acid is an ACL inhibitor used in the management of primary hypercholesterolaemia, mixed dyslipidaemia, and atherosclerotic cardiovascular disease.
• Filgotinib is an orally active Janus kinase (JAK) inhibitor used as a disease-modifying antirheumatic drug (DMARD) in the treatment of moderately to severely active rheumatoid arthritis.
• Risdiplam is a disease-modifying therapy that increases production of functional survival motor neuron protein and is used in the treatment of spinal muscular atrophy.
Proprietary Preparations and Manufacturers updated for the following countries and regions:
• Czech Republic
• Finland
• Netherlands
• South Africa
• Thailand
• UK†
• USA†
† Countries updated on an ongoing basis
This update contains 3 new monographs. Preparations have been updated for 9 countries.
New monographs:
• Brolucizumab, a recombinant humanised monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A), is used for the treatment of neovascular (wet) age-related macular degeneration.
• COVID-19 vaccines are used for active immunisation against COVID-19 disease.
• Enfortumab vedotin is an antibody-drug conjugate used for the treatment of locally advanced or metastatic urothelial cancer.
Notable revisions:
• New treatment review for COVID-19 infection.
Updated names, synonyms and codes; official standards; official preparations:
• Entries for the British Pharmacopoeia have been updated for BP 2020 and BP (Vet) 2020.
Proprietary Preparations and Manufacturers updated for the following countries and regions:
• Belgium
• India
• Ireland
• Norway
• Philippines
• UAE
• UK†
• USA†
• Venezuela
† Countries updated on an ongoing basis
This update contains 3 new monographs and 1 existing monograph has been updated. Preparations have been updated for 4 countries.
New monographs:
• Elapegademase is a recombinant form of the pegylated enzyme adenosine deaminase (pegademase). It is used in the treatment of severe combined immunodeficiency disease associated with a deficiency of adenosine deaminase.
• Lefamulin is a pleuromutilin antibacterial used for the treatment of community-acquired bacterial pneumonia.
• Vestronidase alfa is a recombinant human lysosomal beta-glucuronidase used as enzyme replacement therapy for the treatment of the non-neurological manifestations of mucopolysaccharidosis VII.
Notable revisions:
• Dexamethasone is being tried in the treatment of COVID-19 (coronavirus disease 2019) infection.
Updated names, synonyms and codes; official standards; official preparations:
• Entries for USP and USNF have been updated for USP 43-USNF 38
Proprietary Preparations and Manufacturers updated for the following countries and regions:
• Brazil
• Hong Kong
• UK†
• USA†
† Countries updated on an ongoing basis
