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Viaskin Peanut, the revolutionary “Peanut Patch,” simply introduced that the FDA has accepted their BLA. The BLA is their Biologics License Software, which is a vital component in getting FDA approval.

DBV Applied sciences, the French firm growing the peanut patch, has been on a curler coaster over the previous few years. In complete, Viaskin Peanut has carried out eight medical trials on human topics, involving over 1,000 sufferers and their households. Affected person curiosity continues to develop, which implies elevated media visibility. That additionally implies that they’ve acquired uncomfortable dangerous press throughout routine scientific setbacks.

The street to FDA approval is lengthy, and it’s regular for therapies encounter issues alongside the best way. Failure is a part of the scientific course of, and is at all times a studying expertise.

The media has been notably unkind to DBV in the previous few years. In October of 2017, DBV revealed {that a} higher-than-expected variety of sufferers on placebo in one in every of their trials “responded” to therapy. (Probably they had been naturally outgrowing their allergy.) DBV shares plummeted within the wake of this announcement, after headlines concerning the patch’s “failure.” I revealed my very own rebuttal on the time.

That mud finally settled, and DBV submitted their first BLA, solely to withdraw it in December of 2018. The FDA needed extra info on manufacturing procedures and qc. So DBV withdrew it with the intention to present extra full knowledge, after which resubmit. As soon as once more, the media latched onto this “dangerous information” and ran with it.

It’s been quiet on the DBV entrance for some time now, so I used to be glad to see excellent news final week. The FDA has accepted DBV’s newest BLA. This nonetheless doesn’t imply the FDA has accredited the therapy, however it’s one step nearer. DBV hopes to make Viaskin Peanut obtainable to sufferers within the second half of 2020.

Information supply: https://www.dbv-technologies.com/wp-content/uploads/2019/10/dbv-technologies-announces-fda-acceptance-of-bla-filing-for-viaskin-peanut-for-the-treatment-of-peanut-allergy-10.4.19.pdf