Researchers may be racing to develop new Covid-19 treatments, but normally it has taken slightly more than six years, on average, to test new anti-viral medicines and then win U.S. regulatory approval, according to a new analysis of anti-infective medicines approved over the past two decades.
In fact, between clinical trials and regulatory reviews, the combined time to win Food and Drug Administration approval for all anti-infective medicines between 2000 and 2019 was longer — slightly more than seven years. Meanwhile, the mean time to study and receive approval for all other types of medicines was more than eight years, according to the analysis by the Tufts Center for the Study of Drug Development.
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Some of the decision making is confusing to me. Remdesivir, as you mentioned, it the one antiviral that was shown, in a large, randomized, blinded study, to reduce hospital stay. It appears to have good, but perhaps not outstanding activity against Coronavirus. This was known at the end of May, 2020. Having noted that, Gilead has not attempted to test Remdesivir in early Covid19, at a time when one would expect it to be more active, more valuable… except for just now, when a study of aeresolized Remdesivir is ongoing at three institutions, aiming for a total enrollment of 280 patients. If they are studying the drug at this slow pace, no wonder it may take years to get approved. So just what is slowing down the development? The huge effort is writing up a protocol? No money or unwillingness to spend money to launch a large, meaningful trial? FDA regulations? Lack of willingness of institutions to enroll patients? I don’t know. I have mentioned several times about the prospect of combining antivirals. Remdesivir IV followed by EIDD-2801 for instance. Or Remdesivir IV followed by Favipiravir. These could be excellent treatments but at the rate clinical research is advancing, it may take a year before such combinations are considered. This epidemic is uncommonly serious… why the delays?