From hydroxychloroquine to tocilizumab, passing through heparin: in just under a month, the Technical-Scientific Commission of the Italian Medicines Agency (AIFA) has assessed, thanks to a rapid procedure developed for the coronavirus emergency, as many as 80 applications for authorization to start trials and clinical trials on drugs for patients with Covid-19 .
There are 16 who have had a favorable opinion , 10 of these have already left and the last one concerns colchicine, an old drug used in disorders on an auto-inflammatory basis and in gout. Since the entry into force of the Decree-Law 18/2020, the Aifa Technical-Scientific Commission has been assigned the task of evaluating the clinical study protocols of the experimental therapies used in patients with Sars-Cov-2. The assessments were carried out from 17 March to 13 April by the Commission, meeting in permanent telematic session.
In particular, the latest authorized is an Italian multicenter study on the use of colchicine , coordinated by the Perugia Hospital. Among those who had the green light, the heparin anticoagulant, which involves 14 Italian centers and 300 patients. Several studies concern tocilizumab , anti-inflammatory normally used for rheumatoid arthritis. And yet, one study examines the early administration of hydroxychloroquine, another sarilumab, a monoclonal antibody against interleukin-6.
Yet another is the combination of emapalumab , a monoclonal anti-interferon gamma antibody, with anakinra, a receptor antagonist for interleukin-1. The list also includes Solidarity , the international multicenter study launched by the World Health Organization (WHO). To these are added two clinical studies on the anti-viral remdesivir.
Another 8 studies, however, must finalize the presentation of the documents or are awaiting approval by the Ethics Committee. The remaining questions have a suspensive opinion with a request for additions, have had an unfavorable opinion or have been considered not assessable.
All these drugs are not without side effects, sometimes even important, and the studies aim to understand, in addition to efficacy, also safety. "The speed and the shared methodology of the approval processes - underlines Aifa in a note - represent the basis of an innovative research tool, able to combine the guarantee of safe treatment of patients with the necessary scientific rigor, also in a context of emergency".