Following the news that DBV Technologies has submitted a biologics license application (BLA) to the US FDA for Viaskin Peanut, an epicutaneous immunotherapy for the treatment of peanut allergy, Rose Joachim, PhD, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers her view:
“Although DBV’s recent BLA resubmission for Viaskin Peanut has certainly put the company back on track, the resultant setback is not insignificant. DBV’s main competitor in the peanut allergy immunotherapy space, Aimmune Therapeutics, filed a BLA for its peanut oral immunotherapy (OIT) product, AR-101, within the same month that DBV withdrew its initial BLA. Aimmune anticipates a decision from the FDA in late January 2020 and if approved, plans to launch AR-101 a few months after. With this level of setback for DBV, it is likely that AR-101 will have already launched in the US for several months before DBV has even received a decision from the FDA.
“This first-to-market advantage for AR-101 in the US could be a huge problem for DBV. Based on forecasts from GlobalData’s report: ‘Peanut Allergy: Opportunity Analysis and Forecasts to 2027’ by 2027, the US peanut allergy immunotherapy market will be worth $3.9bn —representing nearly 90% of sales within the 8MM*.
“When the report was published in June 2018, GlobalData projected that Aimmune and DBV would launch their products simultaneously and that AR-101 and Viaskin Peanut would claim 66% and 33% of the market share, respectively. These estimates were based on AR-101’s larger target patient population of 4–17 years vs. 4–11 years, as well as increased efficacy in clinical trials.
“With the schedule change for DBV, it is now unclear whether this projected sales breakdown will remain the same. DBV’s main hope in retaining previously anticipated levels of market-share will likely lie in the ebb and flow of public opinion regarding the risk-benefit profile of OIT. Although Viaskin Peanut has shown milder efficacy in comparison to AR-101, Viaskin Peanut has a better safety profile, particularly when it comes to the risk of systemic reactions. Thus, if public opinion shifts towards being more risk averse in the treatment of peanut allergy, it could be good news for DBV.”
*8MM = US, 5EU, Australia, Canada