[Updated 9:20 p.m., see below.] DBV Technologies is jumping back into the race to bring an FDA-approved peanut allergy treatment to the market, but it might not be enough to beat its main rival.
The France-based company says it expects to resubmit its application for FDA approval of Viaskin Peanut, the company’s experimental peanut allergy treatment, in the third quarter of this year. Wednesday’s announcement comes nearly two months after DBV voluntarily withdrew its application after the FDA asked for more details about manufacturing and quality controls.
Shares of DBV (NASDAQ: DBVT) jumped nearly 18 percent to $8.30 in after-hours trading.
DBV’s announcement is the latest twist in a race between the company and its rival, Aimmune Therapeutics (NASDAQ: AIMT). DBV was the first to file for FDA approval, submitting its application last October. Brisbane, CA-based Aimmune filed its submission in December, putting it two months behind DBV.
[Paragraph updated to clarify timeline.] DBV’s withdrawal of its application in late December appeared to give Aimmune a chance to make up ground, until Aimmune ran into its own obstacles. Last month, Aimmune said that the partial federal government shutdown delayed the agency’s review of its submission, throwing into question the timeline for the FDA’s review. But on Wednesday, company spokeswoman Alison Marquiss said by e-mail that the regulatory review of AR-101 started on Jan. 25. Aimmune now expects to hear from the FDA by late March if the file is complete. After that, the agency will take several months to weigh approval, Marquiss said. During this time, it’s possible an advisory committee is convened; these independent panels assess the benefits and risks of a drug and vote whether to recommend approval.
DBV’s Viaskin Peanut is an immunotherapy administered by a patch applied directly to the skin. The patch contains biological compounds intended to desensitize children to allergens that trigger food allergies. Aimmune’s treatment, AR-101, is taken by mouth. Provided in capsules or sachets that contain peanut protein, the Aimmune treatment was developed to desensitize children to the food allergy with doses that increase over the course of a year.
Even though DBV is on course to refile its application with the FDA, the submission still faces hurdles. Viaskin Peanut failed to meet the main goal of a late-stage trial, which analysts have said makes the patch’s approval far from certain.