NNeewwsslleetttteerr Highlights of updates to NDO in August 2010

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in Prescribing Regulatory changes in the EU Outlook 2009

Launched in the UK Capsaicin patch (Qutenza) Peripheral neuropathic pain in non-diabetic adults

Indacaterol (Onbrez) Chronic obstructive pulmonary disease Tenofovir (Viread) Chronic hepatitis B infection with decompensated liver disease [licence extension] Approved in the EU Velaglucerase alfa (VPRIV) Type 1 Gaucher’s disease Filed for approval in the EU Fidaxomicin Clostridium difficile infections Olmesartan medoxomil + Hypertension amlodipine + hydro- chlorothiazide (Tribenzor) Other EU regulatory developments Bosutinib Chronic myelogenous leukaemia – granted orphan status Dexamethasone (Ozurdex) Uveitis, non-infectious posterior segment – granted orphan status Everolimus (Afinitor) Tuberous sclerosis complex – granted orphan status Midostaurin Mastocytosis – granted orphan status Pixantrone (Pixuvri) Diffuse large B-cell Non-Hodgkin’s lymphoma – granted orphan status Other news Semagacestat Alzheimer’s disease, mild to moderate – development suspended

New monographs added (11) Phase in EU

Dexamethasone (Ozurdex) Uveitis, non-infectious posterior segment PIII Doxorubicin heat sensitive liposomes (ThermoDox) Hepatocellular carcinoma PIII Elinogrel Acute coronary syndrome PII Ethinylestradiol + levonorgestrel Contraception – once weekly patch PIII Fluticasone propionate + formoterol fumarate Asthma Filed (Flutiform) Sapropterin (Kuvan) Phenylketonuria, neuropsychiatric symptoms PIII Scyllo-inositol Alzheimer’s disease, mild to moderate PII Tacrolimus (LCP-Tacro) Kidney transplant rejection PIII Tiotropium (Spiriva) Cystic fibrosis PIII Torezolid Skin and soft tissue infections PIII Zoster vaccine Herpes zoster, shingles PIII

To access New Drugs Online monographs click on the drug name/indication or visit www.ukmi.nhs.uk/ndo

Direct links to abbreviated NDO monographs via NHS Evidence are included if available at the time of publication

Complete monographs are password protected and can be viewed at www.ukmi.nhs.uk/ndo In Aug 2010 | 420 monographs updated | 27 evidence-based evaluations added | 1,723 registered NDO users

NNeewwsslleetttteerr

Focus: Drugs in development for mellitus Phase in EU

Albiglutide (Syncria) SC glucagon-like peptide 1 receptor agonist PIII Oral peroxisome proliferator-activated receptor α/γ co-agonist PIII Oral dipeptidyl peptidase IV inhibitor PIII Balaglitazone Oral partial peroxisome proliferator-activated receptor γ agonist PIII Bardoxolone methyl Oral Nrf2 gene activator PII BI 10773 Oral sodium glucose co-transporter type 2 inhibitor PIII (Cycloset) Oral dopamine D2 receptor agonist None (Approved US) Oral selective sodium glucose co-transporter type 2 inhibitor PIII Canakinumab (Ilaris) IV interleukin 1-beta inhibitor PIII Colesevelam Oral bile acid sequestrant None (Cholestagel) (Launched US) Oral sodium glucose co-transporter type 2 inhibitor PIII Dutogliptin Oral dipeptidylpeptidase-4 inhibitor PIII (Bydureon) SC once weekly incretin mimetic Filed buccal (Oral-lyn) Buccal regular human insulin given using the RapidMist device PII SC soluble long acting insulin analogue – given three times a week PIII Insulin degludec + SC soluble insulin analogue combination with a rapidly acting PIII component and a basal component Insulin inhaled (Afrezza) Inhaled ultra rapid acting human insulin using Technosphere PIII technology Insulin oral Oral human insulin formulated as a tablet with Eligen technology PII Insulin transdermal Transdermal insulin PII (E-TRANS Insulin) (Ondero) Oral dipeptidylpeptidase-4 inhibitor PIII SC exendin-4 analogue PIII LX4211 Oral sodium glucose co-transporter type 2 inhibitor PII LY2189265 SC glucagon-like peptide 1 receptor analogue PIII Melogliptin Oral dipeptidylpeptidase-4 inhibitor PIII Metaglidasen Oral peroxisome proliferator-activated receptor γ agonist PII Oral potassium channel antagonist and insulin secretagogue None (PIII US) Rivoglitazone Oral peroxisome proliferator-activated receptor γ agonist PIII Succinobucol Oral composite vascular protectant PIII SC glucagon-like peptide 1 receptor agonist PIII Valsartan Oral angiotensin II receptor antagonist PIII

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In Aug 2010 | 420 monographs updated | 27 evidence-based evaluations added | 1,723 registered NDO users