DBV craters on FDA’s peanut allergy immunotherapy rejection
DBV Technologies’ long and tortuous path to an FDA verdict on its Viaskin Peanut allergy shot has led to another dead end.
The France-headquartered biotech confirmed the complete response letter (CRL) from the US regulator today, adding another delay to a programme that is already falling well behind a rival therapy developed by Aimmune – Palforzia – which was approved in February.
The agency is asking for a new “human factor study” to examine how well the patch-based product adhere to the skin, and how that affects efficacy, according to DBV. Shares in the company lost more than a third of their value on the announcement.
The biotech initially filed for approval of Viaskin Peanut at the end of 2018, only to withdraw the application a few months later after an FDA request for more information on manufacturing.
It refiled last August, but by March of this year it was clear the application was in trouble over the adhesion issue.
DBV says it plans to request a meeting with the FDA to discuss its comments in the CRL as well, as that may be needed in another clinical trial to support another refiling.
“We are very disappointed in the FDA’s response, but continue to believe in the potential of Viaskin Peanut,” said DBV’s CEO Daniel Tassé.
The rationale behind Viaskin Peanut is to expose people with peanut allergy to small, rising amounts of peanut protein – which acts as an allergen – to encourage the immune system to develop tolerance over time.
While DBV’s product is delivered as a patch on the skin, Palforzia – which was the first drug to treat peanut allergy in the US – is administered as an oral dose and can be given to children aged four to 17. DBV has been seeking approval of its drug for the four to 11 age bracket.
Every month that Viaskin Peanut is kept from the market gives more time for Aimmune’s drug to get established of course, and likely reduces the return DBV could get on its investment.
Analysts have previously suggested that Palforzia could eventually become a $1 billion product, given there are around 1.8 million people with peanut allergy in the US, one million of them under the age of 18.
That said, the pandemic has cut hard into what should have been the strong early period for Aimmune’s first product, with the company reporting just $575,000 in revenue in the first half, and it remains to be seen if that is masking lacklustre take-up.
COVID-19 has also held up a phase 3 trial of Palforzia in younger children aged under four, according to California-based Aimmune.
The biotech is also expecting European approval for Palforzia before the end of the year, and a verdict in Switzerland in the middle of 2021.
Meanwhile, DBV has been restructuring its business to eke out its cash reserves, put at just under €226 million at the end of June.
The company spent almost €80 million in the first half of the year however, and has announced significant job losses to make sure it can continue operating with cash on hand as long as possible. Analysts think it should last into 2022.