DBV Technologies’ struggle to get its peanut allergy therapy approved looks set to drag on, after the US Food and Drug Administration (FDA) asked for more data on the patch-based immunotherapy.
The setback means that DBV’s drug loses further ground as it tries to catch up with Aimmune, whose oral peanut allergy immunotherapy Palforzia became the first drug to claim FDA approval for this indication in February.
The FDA wants more data on how well DBV’s Viaskin peanut patch adheres to the skin, and the impact on its efficacy, as it reviews the Biologics License Application (BLA) for the drug, and has said an advisory committee meeting scheduled to take place on 15 May has been cancelled.
France-based DBV filed for approval of Viaskin Peanut at the end of 2018 in the US, but was forced to withdraw that first application because of FDA concerns about manufacturing data. It refiled the application last August.
In a statement, DBV said it was “in communication with the FDA regarding the potential submission of additional information on patch-site adhesion from its clinical programme”, saying it has evidence that adhesion doesn’t have a material impact on efficacy.
It also intends to submit long-term efficacy results from a three-year open-label extension study, PEOPLE, that it hopes will help answer the US regulator’s questions about the drug.
Like Palforzia, the rationale for Viaskin Peanut is to expose people with peanut allergy to small amounts of antigen over time to encourage the immune system to develop tolerance. The approach isn’t a cure, and people have to continue to avoid eating peanuts, but the hope is that this type of therapy could reduce the risk of serious allergic reactions.
There are around 1.8 million people with peanut allergy in the US, one million of them children, and it is the leading cause of death from food-induced allergic reactions. Around one in five children diagnosed with the allergy eventually outgrows the condition.
As it stands Viaskin peanut still has an FDA action date of 5 August, but DBV says the new data required by the FDA “may constitute a major amendment to the BLA” and so could see that date pushed back.
Every month of delay gives Aimmune more time to extend its lead with Palforzia. Analysts at Baird have suggested that with a weaker clinical profile, the new delay means Viaskin Peanut is “effectively dead in the water”.
The Institute for Clinical and Economic Review (ICER) has already indicated that it thinks Palforzia is cost-effective at the proposed price of between $5,000 to $10,000 for the first six months of use, and $300 to $400 per month thereafter.
Meanwhile, analysts at GlobalData have suggested the market for peanut allergy products in eight major world markets could be worth $4.5bn in 2027, with Aimmune claiming a two-thirds share.