DBV sets sights on FDA resubmission for peanut allergy treatment

• DBV Technologies expects to resubmit its experimental treatment for peanut allergy to the Food and Drug Administration by the third quarter of this year, a speedier-than-expected path back to the regulator after the company withdrew its original application last December.
• “We appreciate the detailed feedback the FDA provided in December 2018, which has allowed us to make meaningful headway in addressing the information requests needed for a BLA resubmission,” said DBV CEO Daniel Tasse in a Feb. 13 statement.
• DBV’s stock rose by more than 10% in Thursday trading on the news. Still, shares in the company remain roughly 50% below price levels seen prior to the company voluntarily pulling its application for approval of the treatment, called Viaskin Peanut.

While DBV’s plans to resubmit Viaskin Peanut later this year clear up a key uncertainty, the treatment remains a long ways away from a regulatory decision and potential launch.

Analysts currently peg a potential approval for the drug in early 2021, accounting for the FDA’s review following resubmission and a potential advisory panel meeting on DBV’s treatment. But that timeline isn’t precise, noted SVB Leerink analyst Joseph Schwartz.

“We remain unclear on timing beyond its BLA resubmission since the FDA is not bound to a timeline with [DBV] since its product is not part of the PDUFA process because allergen extracts are excluded from PDUFA,” wrote Schwartz in a Feb 13 note to investors, referring to the user fee agreement between the FDA and industry that governs regulatory review times.

That same question recently faced investors in DBV’s chief rival, Aimmune Therapeutics, which had submitted its peanut allergy treatment AR101 to the FDA a day before the U.S. government partially shut down on Dec. 22, 2018.

The company had expected review of its therapy to begin, as the FDA had stated products governed by the Prescription Drug User Free Act would be reviewed on schedule if companies submitted prior to the shutdown.

Yet that didn’t happen, leaving investors to wonder whether Aimmune and the FDA were on the same page regarding AR101.

With the government now reopened, review should proceed and set Aimmune up to win a potential U.S. approval for its drug ahead of DBV.

(Congress and President Trump are negotiating a new deal to keep the government open before a Friday deadline at midnight.)

DBV’s decision to pull its application last December stemmed from correspondence between the company and the FDA that indicated DBV’s application lacked needed details on manufacturing procedures and quality control.

DBV expects to have compiled the required information in order to resubmit Viaskin Peanut by the third quarter. According to an investor note from Jefferies analyst Eun Yang, the FDA requested data on quality control test validation, manufacturing procedures and the treatment’s nature as a combination product.

As of Sept. 30, 2018, DBV had 154 million euros in cash and equivalents, enough to fund the company through the fourth quarter of 2019, Jefferies’ Yang wrote.

https://www.biopharmadive.com/news/dbv-sets-sights-on-fda-resubmission-for-peanut-allergy-treatment/548481/