The Food and Drug Administration has accepted an application for another drug to treat children with peanut allergy.
Montrouge, France-based DBV Technologies said Friday that the FDA had accepted its application for Viaskin Peanut, a once-daily patch for the skin designed to potentially reduce the risk of life-threatening allergic reactions due to accidental exposure to peanuts in children aged 4-11. The patch delivers tiny amounts of peanut antigen to activate the immune system.
The FDA is expected to decide whether to approve the application by Aug. 5 of next year and has signaled it will hold an advisory committee meeting to discuss it, the company said. DBV had submitted its approval application for the product before, but withdrew it in December 2018 before resubmitting it in August. The application is based on two Phase III studies, along with four Phase II and two Phase I trials.
Shares of DBV were up 2.6 percent on the Nasdaq Friday afternoon following the news.
“The exciting thing for me about Viaskin is that it’s using the immunologic potential of the skin, and it’s doing this in a very straightforward, simple way, where the patients in the trials weren’t required to modify treatment around exercise or illness,” said Todd Green, DBV’s vice president for medical affairs, in a phone interview. “There’s a pretty straightforward advantage of wearing the patch at home, without dose titrations. Part of what I’ve seen that is appealing to patients is that the simplicity of once-daily treatment doesn’t require a lot of lifestyle modification and is pretty well-tolerated.”
The news comes three weeks after the FDA’s Allergenic Products Advisory Committee voted 7-2 and 8-1 in favor of the efficacy and safety profiles of Aimmune Therapeutics’ Palforzia, or AR101, in children aged 4-17. While the agency had not given Aimmune a specific action date for the application, a spokesperson for the company said at the time that it was expected to decide in January 2020. The FDA is not required to follow advisory committee votes, but usually does.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Palforzia had attracted some concerns from advisory committee members, particularly about its safety due to a higher rate of systemic allergic reactions – including anaphylaxis – patients who received the drug versus those on placebo. The vote in favor of its safety profile was conditional upon the label carrying a Risk Evaluation and Mitigation Strategy, or REMS, requiring that patients have access to epinephrine and that the drug be administered in a facility able to treat allergic reactions. An FDA official stated that the drug’s label would also carry a black-box warning.
The Phase III program for Viaskin Peanut included 700 patients between the two trials, REALISE and PEPITES. Top-line data from REALISE showed that one patient in the treatment arm experienced moderate analphylaxis deemed probably related to treatment, with the treatment and placebo arms respectively experiencing three and two serious adverse events. In published results from PEPITES, the most commonly reported treatment-related adverse events were reactions at the site of the patch, including reddening, itchiness and swelling of the skin, with four treatment-emergent adverse events leading to permanent discontinuation of therapy. Of 26 total cases of anaphylaxis, 10 were determined to be possibly, probably or definitely related to therapy.
Photo: Stephen Lovekin, Getty Images
