NDO Newsletter November 2014

Newsletter
Highlights of updates to NDO in November 2014
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Regulatory changes in the EU
in Prescribing
Outlook 2014
Launched in the UK
Darunavir (Prezista)
HIV infection – use in combination with cobicistat, and in children aged 3 years
and older of at least 15kg bodyweight [licence extension]
Insulin degludec + liraglutide
(Xultophy)
Type 2 diabetes mellitus [new formulation]
Para-aminosalicylic acid (GranuPAS)
Multi-drug resistant tuberculosis
Peginterferon beta-1a (Plegridy)
Multiple sclerosis, relapsing-remitting in adults [new formulation]
Posaconazole (Noxafil)
Fungal infections in adults [IV formulation]
Sofosbuvir + ledipasvir (Harvoni)
Chronic hepatitis C virus infection in adults [new formulation]
Approved in the EU
Aclidinium bromide + formoterol
fumarate (Brimica/Duaklir Genuair)
Chronic obstructive pulmonary disease [new formulation]
Catridecacog (NovoThirteen)
Congenital factor XIII A-subunit deficiency in children aged under six years
[licence extension]
Darunavir + cobicistat (Rezolsta)
HIV infection in treatment-naïve and experienced adults [new formulation]
Dulaglutide (Trulicity)
Type 2 diabetes mellitus in adults
Filgrastim biosimilar (Accofil)
Neutropenia
Nintedanib (Vargatef)
Non-small cell lung cancer in adults – second-line
Raltegravir (Isentress)
HIV infection in patients from the age of four weeks [oral suspension
formulation and licence extension]
EU positive opinions
Apremilast (Otezla)
Chronic plaque psoriasis in adults / Psoriatic arthritis in adults
Dasabuvir (Exviera)
Chronic hepatitis C infection in adults
Eliglustat (Cerdelga)
Type 1 Gaucher’s disease in adults
Nintedanib (Ofev)
Idiopathic pulmonary fibrosis in adults
Ombitasvir + paritaprevir + ritonavir
(Viekirax)
Chronic hepatitis C infection in adults
Ospemifene (Senshio)
Vulvar and vaginal atrophy in postmenopausal women
Secukinumab (Cosentyx)
Plaque psoriasis, moderate-to-severe
Vorapaxar (Zontivity)
Reduction of atherothrombotic events in patients with previous MI
Filed for approval in the EU
Efraloctocog alfa (Elocta)
Haemophilia A – prophylaxis and treatment
Eltrombopag (Revolade)
Severe aplastic anaemia, in patients with an insufficient response to
immunosuppressive therapy [licence extension]
Levodopa + carbidopa ER (Patrome)
Parkinson’s disease – early-stage / late-stage [new formulation]
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 NICE Evidence Search are included
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In November 2014 | 295 monographs updated | 26 evidence-based evaluations added | 4,355 registered NDO users
Newsletter
Filed for approval in the EU (continued)
Lumacaftor + ivacaftor
Cystic fibrosis in in homozygous F508del patients
Nivolumab (Opdivo)
Advanced malignant melanoma, BRAF-negative – first-line
Mepolizumab
Severe, refractory asthma with airway eosinophilia
Oleogel-S10
Accelerated healing of partial thickness wounds
Other EU developments
Balugrastim (Egranli)
Chemotherapy-induced neutropenia [biosimilar] – filing withdrawn
Raxibacumab (ABthrax)
Inhalation anthrax disease – granted orphan drug status
Rilotumumab
Advanced gastric or gastroesophageal cancer – development discontinued
New monographs added (22)
Phase in EU
Afamelanotide (Scenesse)
Vitiligo
PII
Apomorphine sublingual
Parkinson’s disease – treatment of ‘off’ episodes
PIII
Aripazine
Antidote to oral factor Xa inhibitors
Biotin
Multiple sclerosis – primary progressive / secondary progressive
Cabozantinib
Non-small cell lung cancer – second- or third-line
CR845
Postoperative pain
None (PII US)
Dexamethasone (OTX-DP)
Allergic conjunctivitis due to a variety of allergens
None (PII US)
Favipiravir (Avigan)
Ebola virus infection
PII
Idelalisib (Zydelig)
Relapsed chronic lymphocytic leukaemia – in combination with
bendamustine and rituximab
PIII
ITI-007
Schizophrenia
Masitinib
Amyotrophic lateral sclerosis, familial or sporadic / Crohn’s disease
MEDI2452
Antiplatelet reversal for patients taking ticagrelor
Meropenem + RPX7009 (Carbavance)
Serious bacterial infections due to gram-negative bacteria
Nimotuzumab (Theraloc)
Advanced pancreatic cancer – second-line
PII
Nivolumab (Opdivo)
Advanced malignant melanoma – first-line with ipilimumab
PIII
SD-809
Tardive dyskinesia
PIII
Tenofovir alafenamide
Hepatitis B infection in treatment-naïve patients
PIII
Tipiracil + trifluridine (Lonsurf)
Metastatic colorectal cancer
PIII
Tivantinib
Prostate cancer, asymptomatic or minimally symptomatic, metastatic
castrate-resistant
Wannoxyme (DermaPro)
Diabetic foot ulcer
Focus: Drugs in development for cancer cachexia
None (PII US)
PIII / PIII
PII
Unknown (PIII US)
PIII / PIII
Pre-clinical
None (PIII US)
None (PII US)
PIII
Phase in EU
Anamorelin
Oral ghrelin receptor agonist
PIII
Enobosarm (Ostarine)
Oral selective androgen receptor modulator
PIII
MT-102
Oral beta-adrenergic receptor agonist, beta-adrenergic receptor
antagonist and serotonin 1A receptor antagonist
PII
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In November 2014 | 295 monographs updated | 26 evidence-based evaluations added | 4,355 registered NDO users
This is an NHS document not to be used for commercial purposes

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