Peanut Vaccine Fails Trial But FDA May Pass It Anyway

On Friday, a peanut vaccine failed to pass a clinical trial. But that’s not stopping the manufacturer from trying to get the peanut vaccine pushed out to the public, anyways.

DBV Technologies is blaming their peanut vaccines failure on a bad placebo effect. They believe that the FDA is still going to pass the vaccine through so that it can be sold as patches. The official name, Viaskin Peanut, is a patch which DBV claims “trains the immune system” to not react harshly to peanuts.

Here’s the thing, 35% of kids with peanut allergies responded well to Viaskin Peanut. But, the problem is, this didn’t beat the placebo’s margins. This essentially stopped Viaskin in its tracks. However, DBV is hoping that President Trump’s loosening (or encouragement to loosen) FDA approval standards could serve to work in Viaskin’s favor. But investors, of course, don’t like it when pharma medications don’t outperform placebos.

According to PBS

Whether the FDA will consider approving Viaskin remains to be seen. Under Dr. Scott Gottlieb, President Trump’s choice to lead the agency, the FDA has promised to loosen its standards for new therapies that might improve the lives of patients with severe conditions.

Investors, however, were less than optimistic Friday. DBV’s share price fell by about 45 percent on the news, erasing more than $1 billion of the company’s value.

DBV blamed the trial outcome on better-than expected results from placebo. In the study, about 13 percent of patients on placebo saw their peanut allergies improve, a rate that was roughly double what DBV saw in earlier trials, according to Dr. Hugh Sampson, the company’s chief scientific officer.

Sounds like Mr. Peanut may have to wait a bit to attend any launch parties. But stranger things have most certainly happened. A new safety trial for Viaskin will show its results next month.