In January, MedPage Today covered the FDA’s approval of an oral peanut allergy immunotherapy, which was seen as heralding a new era in food allergy treatment. In this follow-up feature, we review some of the developments occurring since.
The timing probably couldn’t have been worse for the product’s developer, California-based Aimmune Therapeutics. The day its flagship product, tradenamed Palforzia, won FDA approval — Jan. 31, 2020 — was also the day that the U.S. government declared a public health emergency for the “novel coronavirus,” which hadn’t yet earned the moniker COVID-19.
And as a few isolated cases outside China turned into a global catastrophe, Aimmune’s commercial expectations took a big hit.
Allergy clinics were among the many specialties deemed “non-essential” that were forced to curtail operations or shut down completely during the pandemic. As the company explained in its review of first-quarter operations, “The COVID-19 pandemic has paused the commercial launch of Palforzia. Under the Risk Evaluation and Mitigation Strategy, or REMS, for Palforzia, the first dose of each up-dosing level must be administered in a certified healthcare setting and, due to the strains placed on the providers of healthcare services by COVID-19, including shelter-in-place restrictions, many patients are not able to access physicians in a manner sufficient to commence treatment with Palforzia.” For the same reason, patients who had already started treatment had to pause their up-dosing.
Aimmune announced the first patient dosing in regular practice on March 16, the week that lockdowns began in earnest in New York and other hotspots.
By summer, though, Palforzia’s rollout had begun to gain momentum. Aimmune said in a July 30 statement that “nearly 1,000 allergists and 600 allergy practices” had gained the certifications necessary to administer the product. “Approximately 100 allergists have enrolled patients in the REMS, and half of these allergists have enrolled more than one patient,” the company said. As well, insurers covering some 102 million people had agreed to cover the treatment to some extent, according to the statement.
Still, the company reported zero product revenue in the second quarter.
But the company — or at least its shareholders — got another boost in August, when consumer products giant Nestlé agreed to buy Aimmune for $2.6 billion. That deal closed in October — meaning there were no further announcements on Palforzia’s commercial performance.
Another vote of confidence came from European Union regulators, who approved Palforzia on Dec. 21. That paves the way for the treatment’s launch in another major market.
DBV’s Transdermal Therapy
Although Palforzia is the first peanut allergy immunotherapy to win approval in the U.S. and Europe, it was expected to face almost immediate competition from a product developed by a French company, DBV Technologies.
While Palforzia is a standardized peanut protein extract that patients take orally in exacting quantities, DBV’s Viaskin therapy is a transdermal patch intended to deliver peanut allergens into the epidermis. This form of administration was seen as potentially more attractive to allergists and patients than Aimmune’s powder. And in early January, DBV released topline results from an extension of the product’s pivotal trial, indicating durable benefit. FDA approval was expected to follow, pending an advisory committee’s review slated for May.
But that meeting didn’t take place. Instead, in March the FDA sent DBV a dreaded Complete Response Letter, in which the agency questioned the patch’s adhesiveness in real-world use and thus the therapy’s effectiveness.
A follow-up FDA letter in August appeared to double down on the agency’s concerns, telling DBV that “the FDA cannot approve the application in its present form,” the company said. The FDA told DBV that it must modify the patch’s design, and thus would need to conduct “a new human factor study” to demonstrate that the adhesion problems are solved.
The company subsequently replaced its top scientific, commercial, and financial officers, and has so far said nothing publicly about its U.S. plans, other than “engaging FDA to discuss” the way forward. Nevertheless, DBV’s struggles with the FDA haven’t stopped it from seeking European approval for the Viaskin product in its current form.