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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 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
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
