Table 1.
Randomized active-control trials of new active substances in EU (1999–2005)
| 1. New medicines with premarketing RaCT | |
| a. New mechanism of action | b. Similar mechanism of action |
| aripiprazole, atosiban, bevacizumab (1), cetrorelix, darifenacin, enfuvirtide, fondaparinux, fulvestrant, ibritumomab tiuxetan (1), ivabradine, leflunomide, rasburicase (1), rosiglitazone, sirolimus, trastuzumab (1) | abacavir, amprenavir, atazanavir, bimatoprost, bivalirudin, brinzolamide, capecitabine, choriogonadotropin alpha (1), darbepoetin alpha (1), deferiprone, efavirenz, emedastine, emtricitabine, epoetin delta (1), ertapenem, fosamprenavir, ganirelix, insulin aspart (1), insulin detemir (1), insulin glargine (1), insulin glulisine (1), interferon alfacon-1 (1), lopinavir, nateglinide, norelgestromin, olopatadine, palonosetron, parecoxib, pegfilgrastim (1), peginterferon alpha-2a (1), peginterferon alpha-2b (1), pioglitazon, rasagiline, sevelamer, telithromycin, temozolomide, tenecteplase (1), tipranavir, travoprost, valdecoxib, voriconazole, zaleplon, zoledronic acid |
| 2. New medicines without premarketing RaCT | |
| a. New mechanism of action | b. Similar mechanism of action |
| agalsidase alpha (1,2), agalsidase beta (1,2), alemtuzumab (1), anagrelide (2), anakinra (1), aprepitant, arsenic trioxide (2), becaplermin (1), bexarotene, bortezomib, bosentan (2), carglumic acid (2), caspofungin, cetuximab (1), cinacalcet, efalizumab (1), eflornithine, eptotermin alpha (1), erlotinib, human protein C (1), imatinib (2), infliximab (1), laronidase (1,2), levetiracetam, memantine, miglustat (2), mitotane (2), nitisone (2), nitric oxide, omalizumab (1), palifermin (1), palivizumab (1), pegvisomant (1,2), pregabalin, sodium oxybate (2), sodium phenylbutyrate, strontium ranelate, tasonermin (1), teriparatide (1), ziconotide (2), zonisamide | adalimumab (1), adefovir, alitretinoin, botulinum toxin b, calcitonin salmon (1), colesevelam, daclizumab (1), desloratadine, dibotermin alpha (1), drotrecogin alpha (1), duloxetine, eptifibatide, etanercept (1), human fibrinogen/thrombin (1), lutropin alpha (1), moroctocog alpha (1), oseltamivir, posaconazole, tadalafil, temoporfin, tenofovir, vardenafil, verteporfin |
1 = biotechnological product; 2 = orphan drug.