NDO Newsletter February 2014

Newsletter
Highlights of updates to NDO in February 2014
NDO home | Contact | Register for NDO access
Regulatory changes in the EU
in Prescribing
Outlook 2013
Launched in the UK
Botulinum toxin A (Botox)
Stroke-associated ankle disability [licence extension]
Canagliflozin (Invokana)
Type 2 diabetes mellitus in adults
Cobicistat (Tybost)
HIV infection in adults
Dimethyl fumarate (Tecfidera)
Multiple sclerosis, relapsing-remitting
Dolutegravir (Tivicay)
HIV infection in adults and adolescents from age 12 years
Elvitegravir (Vitekta)
HIV infection in adults
Lipegfilgrastim (Lonquex)
Chemotherapy-induced neutropenia
Sofosbuvir (Sovaldi)
Hepatitis C infection in adults
Solifenacin + tamsulosin (Vesomni)
Benign prostatic hyperplasia-associated lower urinary tract symptoms [new
formulation]
Ulipristal (Esmya)
Uterine fibroids – repeat three-month treatment course after previous pre-operative
treatment of moderate to severe symptoms [licence extension]
Approved in the EU
Autologous cultured chondrocytes
(MACI)
Full-thickness cartilage defects of the knee in adults
Brimonidine (Mirvaso)
Rosacea facial erythema in adults [new formulation]
Ethinylestradiol + gestodene
Contraception [transdermal formulation]
Somatropin
Growth hormone deficiency [once-weekly formulation]
EU positive opinions
Budesonide + formoterol (DuoResp
Spiromax)
Asthma and chronic obstructive pulmonary disease [new formulation]
Canagliflozin + metformin IR
(Vokanamet)
Type 2 diabetes mellitus
Elosulfase alfa (Vimizim)
Mucopolysaccharidosis IVA (Morquio syndrome)
Follicle stimulating hormone
biosimilar (Bemfola)
In vitro fertilisation
Propranolol (Hemangiol)
Proliferating infantile haemangioma [new formulation]
Rituximab (MabThera)
Non-Hodgkin's lymphoma [subcutaneous formulation]
Umeclidinium (Incruse)
Chronic obstructive pulmonary disease
Umeclidinium + vilanterol (Anoro)
Chronic obstructive pulmonary disease
Filed for approval in the EU
Apixaban (Eliquis)
Treatment of deep vein thrombosis and pulmonary embolism, and prevention of their
recurrence [licence extension]
Cangrelor
Prevention of thrombosis in patients undergoing CABG
Ciclosporin (Restasis)
Keratoconjunctivitis sicca, moderate-to-severe [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
Complete monographs are password protected and can be viewed at www.ukmi.nhs.uk/ndo
In February 2014 | 576 monographs updated | 34 evidence-based evaluations added | 3,797 registered NDO users
Newsletter
Filed for approval in the EU (continued)
Dinutuximab (Unituxin)
Neuroblastoma in children
Indacaterol + glycopyrronium bromide
(Ultibro Breezhaler)
Asthma [licence extension]
Levofloxacin (Aeroquin)
Cystic fibrosis-associated Pseudomonas aeruginosa infection [new formulation]
Liraglutide (Victoza)
Type 2 diabetes mellitus – in combination with basal insulin [licence extension]
Lisdexamfetamine dimesylate (Elvanse)
Attention-deficit hyperactivity disorder, newly-diagnosed in adults [licence
extension]
Netupitant + palonosetron
Chemotherapy-induced nausea and vomiting [new formulation]
Oritavancin (Nuvocid)
Complicated bacterial skin and skin structure infections
Sofosbuvir + ledipasvir
Chronic hepatitis C virus genotype 1 infection in adults [new formulation]
Tedizolid phosphate
Acute bacterial skin and skin structure infections
Other EU developments
Amikacin liposomal (Arikace)
Nontuberculous mycobacterial lung disease – issued a positive opinion for
orphan drug status
Ataluren (Translarna)
Duchenne muscular dystrophy – company requests re-examination of negative
opinion
Eculizumab (Soliris)
Prevention of delayed graft function after solid organ transplantation – granted
orphan drug status
Hepatitis B vaccine (Heplisav)
Hepatitis B – filing withdrawn
Icatibant (Firazyr)
ACE inhibitor-induced angioedema – filing withdrawn
Masitinib (Masiviera)
Pancreatic cancer, advanced – company requests re-examination of negative
opinion
Ridaforolimus (Jenzyl)
Breast cancer / Endometrial cancer / Prostate cancer / Soft tissue and bone
sarcoma – development discontinued
Sofosbuvir + ledipasvir
Chronic hepatitis C virus genotype 1 infection in adults – opinion on a
compassionate use programme announced
Tanezumab
Osteoarthritis – development suspended
New monographs added (27)
Phase in EU
Afuresertib
Multiple myeloma – combination therapy
None (PII US)
Bevacizumab biosimilar – ABP 215
Non-small cell lung cancer, advanced
PIII
c1 inhibitor (human) (Cinryze)
Hereditary angioedema – prophylaxis in children aged 6 to 11
PIII
Delafloxacin
Uncomplicated urogenital gonorrhoea
None (PIII US)
EBI-005
Dry eye
None (PIII US)
EMA401
Postherpetic neuralgia
Evolocumab
Homozygous familial hypercholesterolaemia
PIII
Febuxostat (Adenuric)
Tumour lysis syndrome
PII
Gantenerumab
Alzheimer’s disease, mild
PIII
Ibodutant
Irritable bowel syndrome, diarrhoea-predominant
PII
Insulin glargine biosimilar – MK-1293
Type 1 and type 2 diabetes mellitus
PIII
IPI-145
Chronic lymphocytic leukaemia or small cell lymphoma, refractory
or relapsed
PIII
If you do not wish to continue receiving NDO Newsletter log in and update your profile at www.ukmi.nhs.uk/ndo
In February 2014 | 576 monographs updated | 34 evidence-based evaluations added | 3,797 registered NDO users
This is an NHS document not to be used for commercial purposes
None
Newsletter
New monographs added (continued)
Phase in EU
ISIS-SMNRx
Spinal muscular atrophy
PII
Losmapimod
Acute coronary syndrome
PII
Lubiprostone (Amitiza)
Irritable bowel syndrome, constipation-predominant, in women
Masitinib
Prostate cancer, metastatic, castrate-resistant – first-line
combination therapy
PIII
Mepolizumab
Eosinophilic granulomatosis with polyangiitis
PIII
Mercaptamine bitartrate
Huntington's disease
PIII
Muscle derived cells-urethral sphincter
repair
Stress incontinence
Nivolumab
Non-small cell lung cancer, stage IV or recurrent PD-L1 – first-line
PIII
OMS824
Huntington’s disease
PII
Palbociclib
Breast cancer in patients at high risk of recurrence postneoadjuvant therapy
PIII
PBT2
Huntington's disease
None (PII US)
Ragweed allergy therapy (Ragwitek)
Allergic rhinitis
None (Positive
opinion US)
Ramucirumab (Cyramza)
Colorectal cancer – second-line combination therapy
PIII
Ramucirumab (Cyramza)
Non-small cell lung cancer – second-line combination therapy
PIII
Recombinant human antithrombin iii
(ATryn)
Pre-eclampsia
None (Launched US)
Focus: Drugs in development for lung cancer
PIII
None (PIII US)
Phase in EU
Non-small cell lung cancer
Afatinib (Giotrif)
Oral dual EGFR and HER2 inhibitor – second-line in squamous disease
/ third or fourth-line
Alectinib
Oral ALK inhibitor
PII
Apricoxib (Capoxigem)
Oral selective COX-2 inhibitor
PII
Astuprotimut-R
IM oncology vaccine
PIII
Bavituximab
IV angiogenesis inhibitor
PIII
Belagenpumatucel-L (Lucanix)
Intradermal antisense-DNA vaccine
PIII
Belinostat
Oral HDAC inhibitor
Bevacizumab (Avastin)
IV VEGF antagonist – adjuvant therapy
PIII
Bevacizumab biosimilar – ABP 215
IV VEGF antagonist
PIII
Ceritinib
Oral ALK inhibitor – first-line / second plus-line
Cisplatin liposomal (Nanoplatin)
IV formulation that delivers cisplatin directly into cancer cells
PIII
Custirsen
IV clusterin inhibitor and antisense oligonucleotide
PIII
Dabrafenib (Tafinlar)
Oral BRAF inhibitor
Dacomitinib
Oral pan-HER inhibitor – first-line / second-line
Dimesna (Tavocept)
IV antioxidant
PIII
Entinostat
Oral histone deacetylase inhibitor
PII
If you do not wish to continue receiving NDO Newsletter log in and update your profile at www.ukmi.nhs.uk/ndo
In February 2014 | 576 monographs updated | 34 evidence-based evaluations added | 3,797 registered NDO users
This is an NHS document not to be used for commercial purposes
PIII /
Suspended
PII
PIII / PIII
PII
PIII / PIII
Newsletter
Focus: Drugs in development for lung cancer
Phase in EU
Non-small cell lung cancer (continued)
Erlotinib (Tarceva)
Oral EGFR inhibitor – adjuvant therapy / maintenance treatment
Fosbretabulin (Zybrestat)
IV cadherin 5 inhibitor
PII
Ganetespib
IV heat shock protein 90 inhibitor
PIII
Gefitinib (Iressa)
Oral EGFR inhibitor – second-line after first-line gefitinib
PIII
Ipilimumab (Yervoy)
IV human antibody against CTLA-4
PIII
Lambrolizumab
IV humanised monoclonal IgG4 antibody against PD-1 protein
PIII
MPDL3280A
IV immunotherapy involving PD-L1 protein
PIII
Necitumumab
IV EGFR antagonist – non-squamous / squamous
Nimotuzumab (Theraloc)
IV EGFR-targeting monoclonal antibody
Nintedanib (Vargatef)
Oral VEGFR-2, fibroblast growth factor receptor and platelet-derived
growth factor receptor inhibitor
Nivolumab
IV PDCD 1 inhibitor – first-line / second-line
Onartuzumab
IV monovalent 5D5 anti-c-Met monoclonal antibody
Paclitaxel albumin-bound (Abraxane)
IV tubulin inhibitor – first-line / maintenance
Pralatrexate (Folotyn)
IV apoptosis stimulant, dihydrofolate reductase inhibitor and DNA
synthesis inhibitor
PII
Ramucirumab (Cyramza)
IV VEGFR-2 antagonist
PIII
Selumetinib
Oral selective and uncompetitive MEK kinase inhibitor
PIII
Talactoferrin alfa
Oral dendritic cell recruiter and activator
PIII
Tecemotide (Stimuvax)
SC cancer vaccine – induces a specific immune response to MUC-1
PIII
Tergenpumatucel-L (HyperAcute Lung)
Intradermal immunotherapy
None (PIII US)
Tertomotide
Intradermal telomerase vaccine
None (PIII US)
TG4010
SC therapeutic vaccine
PIII
Vinflunine (Javlor)
IV vinca-alkaloid microtubule inhibitor
PIII
PIII / Filed
PIII / PIII
None (PII US)
Filed
PIII / PIII
PIII
PIII /
None (PIII US)
Small cell lung cancer
Amrubicin (Calsed)
IV topoisomerase II inhibitor
Ipilimumab (Yervoy)
IV human antibody against CTLA-4
PIII
Palifosfamide (Zymafos)
IV alkylating agent
PII
Reovirus (Reolysin)
IV immunomodulator
If you do not wish to continue receiving NDO Newsletter log in and update your profile at www.ukmi.nhs.uk/ndo
In February 2014 | 576 monographs updated | 34 evidence-based evaluations added | 3,797 registered NDO users
This is an NHS document not to be used for commercial purposes
Unknown
None (PII US)

Download Report