New mechanisms of 2015
| Proprietary name | Active substance | Marketing authorisation holder | Authorisation date | Orphan drug? | Mechanism of action | Category | Indication |
|---|---|---|---|---|---|---|---|
| Zykadia | ceritinib | Novartis | 06-05-2015 | no | ALK inhibition | Cancer | ALK-positive, locally advanced or metastatic non-small cell lung cancer |
| Opdivo | nivolumab | Bristol-Myers Squibb | 19-06-2015 | no | PD-1 receptor antagonism | Cancer | Melanoma, non-small cell lung cancer |
| Keytruda | pembrolizumab | Merck Sharp & Dohme | 17-07-2015 | no | PD-1 receptor antagonism | Cancer | Advanced melanoma |
| Unituxin | dinutuximab | United Therapeutics Europe | 14-08-2015 | yes | GD2 binding | Cancer | High-risk neuroblastoma |
| Blincyto | blinatumomab | Amgen Europe | 23-11-2015 | yes | Bispecific CD19-directed CD3 T-cell engagement | Cancer | Philadelphia chromosome negative B-precursor acute lymphoblastic leukaemia |
| Imlygic | talimogene laherparepvec | Amgen Europe | 16-12-2015 | no | Oncolytic virus | Cancer | Melanoma |
| Repatha | evolocumab | Amgen Europe | 17-07-2015 | no | PCSK9 inhibition | Cardiovascular | Hypercholesterolaemia and mixed dyslipidaemia |
| Praluent | alirocumab | Sanofi-Aventis | 23-09-2015 | no | PCSK9 inhibition | Cardiovascular | Hypercholesterolaemia and mixed dyslipidaemia |
| Entresto | sacubitril/valsartan | Novartis | 19-11-2015 | no | Neprilysin inhibition/AT1 receptor antagonism | Cardiovascular | Symptomatic chronic heart failure with reduced ejection fraction |
| Praxbind | idarucizumab | Boehringer Ingelheim International | 20-11-2015 | no | Dabigatran inhibition | Haematology and haemostaseology | Rapid reversal of dabigatran anticoagulant effects |
| Sivextro | tedizolid | Merck Sharp & Dohme | 23-03-2015 | no | Oxazolidinone antibiotic (prodrug) | Infections | Acute bacterial skin and skin structure infections |
| Hetlioz | tasimelteon | Vanda Pharmaceuticals | 03-07-2015 | yes | Melatonin receptor agonism | Other | Non-24-hour sleep-wake disorder |
| Orkambi | lumacaftor/ivacaftor | Vertex Pharmaceuticals | 19-11-2015 | no | CFTR potentiation | Pneumonology | Cystic fibrosis |
| Nucala | mepolizumab | GlaxoSmithKline | 02-12-2015 | no | IL-5 inhibition | Pneumonology | Severe refractory eosinophilic asthma in adult patients |
| Fexeric | ferric citrate coordination complex | Keryx Biopharma | 23-09-2015 | no | Dietary phosphate precipitation | Uro-nephrology | Hyperphosphataemia in chronic kidney disease |
ALK = anaplastic lymphoma kinase; AT1 = angiotensin II receptor, type 1; CFTR = cystic fibrosis transmembrane conductance regulator; PCSK9 = proprotein convertase subtilisin/kexin type 9; PD-1 = programmed cell death protein 1.