DBV Technologies has all but solidified its runner up status in the race to bring a peanut allergy treatment on to the United States market. The French drug developer on Wednesday said it would resubmit an application to market its product — Viaskin Peanut — in the third quarter, after withdrawing its application late last year in response to FDA concerns about the state of manufacturing and quality control data submitted. Meanwhile, arch rival Aimmune’s treatment AR101 is currently under FDA review.
DBV $DBVT rescinded an application to market its peanut allergy patch on December 20, and the following day, Aimmune $AIMT submitted its application for peanut allergy immunotherapy AR101, in effect leapfrogging its competition for a first-mover shot at capturing the so far untapped market, which is expected to grow to $4.5 billion in 2027 globally, according to GlobalData. The US shutdown began on December 22 after President Trump insisted on $5.7 billion from Congress to build a wall on the southwest US border.
By mid-January, Aimmune said the health regulator had notified them that it would not be able to review the application until the lapse in appropriations ended. Ten days later, on January 25th, the government reopened, and the AR101 application was back in contention.
Baird’s Brian Skorney said DBV’s update made no difference to his expectations.
We continue to expect that, should Viaskin Peanut reach an AdCom, the anticipated prior approval of AR101 will eliminate the “there is nothing else available” argument for DBV Technologies and patient advocates, making it more difficult for these parties to make a strong case for approval of Viaskin Peanut, given the medication’s weak efficacy profile. We believe that this dynamic may ultimately prevent Viaskin Peanut from gaining regulatory approval, clearing the field for Aimmune’s AR101.
Meanwhile, when Aimmune announced that the government shutdown had stymied its application, FDA commissioner Scott Gottlieb threw another spanner in the works, suggesting in a series of tweets that allergenic products are not covered by user-fees, and consequently do not qualify for the PDUFA process.
For Aimmune’s immunotherapy, there is no clarity on its PDUFA status, although the company is working with the agency to figure what the timeline for its review is, Skorney noted.
DBV’s Viaskin Peanut — which is derived from freeze-dried defatted peanut flour extracted from raw peanuts — is an allergenic extract and has secured the FDA’s breakthrough therapy designation (BTD) status. Jefferies analyst Eun Yang suggested that the treatment’s BTD status would prompt the FDA to complete its review under the priority review timeline, citing a regulatory expert. Viaskin Peanut is classified as a combination product, thus, it will be reviewed by the CBER (Center for Biologics Evaluation and Research) with consultation from the CDRH (Center for Devices and Radiological Health), although CDRH tends to be slow, Yang said, referring to the expert’s comments.
Leerink forecast a US market entry in 2021 for Viaskin Peanut “given the lack of (regulatory) visibility.”
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