The company withdrew its initial BLA in December after the FDA requested more information regarding manufacturing procedures and quality controls.
After an eight month delay, France-based DBV Technologies announced it resubmitted a Biologics License Application to the U.S. Food and Drug Administration for its Viaskin Peanut treatment, its non-invasive allergy patch.
Viaskin Peanut is the company’s lead product candidate based on epicutaneous immunotherapy (EPIT) aimed at treating peanut allergies in children ages four to 11. DBV’s Viaskin is a proprietary, investigational platform that is designed to leverage the skin to activate the immune system and induce desensitization to allergens. If approved, Viaskin Peanut – the first and only epicutaneous immunotherapy patch – could potentially safeguard children against allergic reactions from accidental peanut exposure without the need to ingest actual peanut protein.
DBV initially submitted a BLA for Viaskin Peanut last year, but withdrew the application in December after the FDA requested more data regarding manufacturing procedures and quality controls. There were no concerns regarding the safety and efficacy of the Viaskin Peanut product.
DBV Chief Executive Officer Daniel Tassé called the resubmission of the BLA an important milestone for the company. Resubmitting the BLA means the company is “one step closer towards potentially bringing Viaskin Peanut to patients,” Tassé said. Putting Viaskin Peanut into the hands of patients will help address a significant unmet medical need, he added.
“We would also like to thank our investigators, clinical trial sites, as well as the children living with peanut allergy and their families for all of their help in the development of Viaskin Peanut. We look forward to working with the FDA throughout its review process,” Tassé said in a statement.
Viaskin Peanut received Breakthrough and Fast Track Designation from the FDA in 2015 and 2012, respectively. The BLA for Viaskin Peanut is supported by a global development program comprised of eight clinical trials including, two Phase I studies, four Phase II studies and two Phase III studies. The two double-blind placebo-controlled Phase III trials, PEPITES and REALISE, studied patients aged 4 to 11 years for 12 months and 6 months, respectively, and were included in the submission. In February, DBV published detailed Phase III data in The Journal of the American Medical Association that showed a significant difference in responder rates between Viaskin Peanut and placebo. According to a post-hoc analysis, 62.6% of patients receiving Viaskin Peanut showed an increase in their eliciting dose at 12 months of treatment. Data from the study showed that Viaskin Peanut administered once-daily on the skin demonstrated clinically meaningful desensitization in peanut-allergic children.
It wasn’t all smooth sailing though. In 2017, DBV reported its Phase III peanut allergy trial failed to show a statistically significant response against placebo. However, in February 2018, the company received permission to seek approval from the FDA, despite the Phase III problems.
While DBV awaits to see if the FDA accepts its BLA, another company developing a treatment for peanut allergies is anticipating an FDA advisory committee is expected to weigh in on its allergy treatment in September. California-based Aimmune’s AR101 has demonstrated effectiveness in more than 67% of juvenile patients. AR101 is an oral biologic desensitization therapy that is sprinkled over food before eating. In June, Aimmune released additional data that showed an extension of daily therapy with its experimental AR101 asset significantly improved tolerability to peanut allergies.
