Dbv technologies provides update on viaskin peanut for children four to 11 years of age bla withdrawn nov 20, 2018 dbv technologies presents data at acaai 2018 on investigational viaskin peanut for the treatment of peanutallergic children. Safety of epicutaneous immunotherapy for the treatment of. Dbv technologies reports positive threeyear, longterm data from the people phase iii openlabel extension study of viaskin peanut in children with peanut. This fundraising will assist in financing the development and preparation for the commercialization of its anti peanut allergy patch, viaskin peanut subject to approval by regulatory authorities, as well as in advancing the development of its sister projects. Dbv s robust development program includes ongoing clinical trials of viaskin peanut and viaskin milk and preclinical development of viaskin egg. The company said it didnt hit its main goal of achieving more tolerance with the patch than the placebo. Hence, there is an important unmet medical need for efficient and safe treatment of peanut allergy. A company called dbv technologies, a french biotech company are developing an allergy treatment patch called viaskin for milk and peanut allergies. Containing a dry layer of allergen in its center, the patch is positioned on intact skin. Dbv technologies peanut allergy drug fails key study reuters. Dbv technologies, the makers of the viaskin peanut patch immunotherapy, and aimmune therapeutics, the company behind ar101, a standardized protocol for oral immunotherapy, both presented data at the european academy of allergy, asthma and immunology eaaci conference held in munich in may 2018. A dbv technologies provides update on viaskin peanut bla for children ages 411 years dbv technologies s. French biotech dbv technologies bid for the us approval of a skin patch to treat nut allergies could be delayed as the fda requested more information on the patch s efficacy.
Food and drug administration fda for the treatment of peanut allergy in children ages four to 11. Dbv technologies the french company pioneering epicutaneous immunotherapy epit or patch therapy for a number of food allergies announced today they completed a phase iii study for their viaskin peanut therapy. Dbv technologies has been testing a patch meant to ease allergic reactions to peanuts. The peanut patch describes a new treatment in development by dbv technologies or dbv. Dbv technologies reports positive threeyear, longterm. Each day, study participants applied a new patch to their arm or between their shoulder blades. Hope remains for the viaskin peanut patch allergic living. Atlanta luis salmun, md, senior vice president, global medical affairs, dbv technologies, outlined some of the projects in the companys pipeline.
To counter that, dbv technologies is working on a patch designed to lessen that severity, reducing the risk of accidental exposure. Dbv technologies rolled out a peanut allergy awareness campaign with actress tia mowry after filing for fda approval of its viaskin peanut patch. Sampson is also chief scientific officer of dbv technologies, which is developing the new peanut allergy patch. Viaskin peanut patch back on the fda approval track for. Dbv technologies to present detailed safety and efficacy data of viaskin peanut at aaaai 2020. Dbv technologies announced positive topline results from the phase 3 people trial of viaskin peanut for the treatment of peanut allergic children aged 4 to 11 years viaskin peanut is an. Dbv technologies has developed an epicutaneous delivery system, called viaskin, a method based on delivering precise quantity of the allergen on the upper layers of the skin. Viaskin is based on epicutaneous immunotherapy, or. Food and drug administration fda for viaskin peanut for the treatment of peanut. We have continually brought new electronic data recording devices and software to researchers everywhere. Dbv technologies, the french company that developed the viaskin peanut patch, announced in october that while 35. Montrouge, francebased dbv technologies said friday that the fda had accepted its application for viaskin peanut, a oncedaily patch for the skin designed to potentially reduce the risk of. Montrouge, francebased dbv technologies said monday night that a meeting of the fdas allergenic products advisory committee to discuss its approval application for the viaskin peanut patch.
Encouraging results the viaskin patch was tested on 221 patients aged 6 to 55. Dbv technologies is continuing to test the viaskin peanut patch on children. Dbv technologies to present detailed safety and efficacy. Dbv technologies released topline data from the first phase iii trial of its highly awaited immunotherapeutic skin patch for peanut allergyviaskin peanut.
The viaskin peanut patch is designed to desensitize allergic children aged 4 to 11 through a skin patch method known as epicutaneous immunotherapy. After an eight month delay, francebased dbv technologies announced it resubmitted a biologics license application to the u. Specifically, the fda requested more information on patch site adhesion critical to the patch working effectively as well as its longterm efficacy. Food and drug administration approval to sell its experimental peanutallergy patch, reassuring investors about the products prospects. Biopharmaceutical company dbv technologies will receive a marketing decision on their novel pediatric epicutaneous immunotherapy epit in the near futureapproximately 8 months after the company withdrew an application. The company has announced it completed phase i of its trial for viaskin milk and is awaiting protocol approval from regulators to begin phase ii. Viaskin peanut patch increases protection from allergy. Dbv technologies provides update on viaskin peanut bla for.
Safety of epicutaneous immunotherapy for the treatment of peanut allergy. Dbv technologies sa said on friday its peanut allergy treatment did not meet the main goal in a highly anticipated latestage study, sending its u. Our innovations include the classic graingage, high capacity graingage, mirus harvest software, and other forwardthinking and innovative technologies in the world of. In july 2010, dbv technologies initiated the first clinical trial of viaskin peanut in the united states, a phase ib trial to evaluate the safety and tolerability of repeated epicutaneous administration of viaskin peanut in patients allergic to peanuts. Longterm data support benefits of viaskin peanut patch. Viaskins potential to unlock the immune properties of skin makes it a promising therapeutic approach beyond food allergies. Dbvt today announced the submission of a biologics license application bla to the u. Montrouge, francebased dbv technologies said monday night that a meeting of the fdas allergenic products advisory committee to discuss its. Harvestmaster is the leader in research agriculture technologies. Dbv technologies announces fda acceptance of bla filing. In december, dbv technologies withdrew the bla after the fda told the french pharmaceutical company that the application to lacked sufficient detail regarding data on. Patch progress, peanut oit in adults data presented at. The company is in communication with the fda regarding the potential submission of additional information on patch site adhesion from its clinical program as well as longterm.
Viaskin epicutaneous immunotherapy dbv technologies. The accumulation of water solubilizes the allergen. Results of two controlled clinical trials were included in the submission. Viaskin peanut patch submitted to fda for approval. The biologics license application bla for potential skin patch peanut allergy treatment viaskin peanut has been submitted to the us food and drug administration fda. Food and drug administration for its viaskin peanut treatment, its noninvasive allergy patch viaskin peanut is the companys lead product candidate based on epicutaneous immunotherapy epit aimed at treating peanut allergies in children ages four to 11.
According to dbv, the company is engaging with the fda and. In new phase two data presented at the american academy of allergy, asthma, and immunology conference on sunday, the company showed that 83% of children ages 6. Dbv technologies dbvt revealed on friday that latestage clinical trials for its patch vaccine, viaskin peanut, missed the primary endpoint. Dbv technologies peanut allergy treatment hits fda setback. We have a comprehensive clinical research program in place for viaskin peanut. Dbv applies for fda license to sell viaskin peanut patch. Pepites is expected to enroll approximately 330 patients in about 30 centers across north america canada and the united states, europe, and australia. Peanut allergy treatments available in 2019 from aimmune. Fda cancels adcom meeting for dbvs peanut allergy patch. Then, in february of this year, the company announced they had secured a meeting with the fdas allergenic products advisory committee apac for may 15 to discuss the application with. Fda has questions about viaskin peanut efficacy, delays. A dbv technologies provides update on viaskin peanut. Dbv s viaskin peanut has obtained fast track and breakthrough therapy designation from the u. Viaskin peanut peanut immunotherapy fda approval status.
The patches were developed and provided by the biopharmaceutical company dbv technologies under the trade name viaskin. Dbv technologies vp discusses peanut allergy patch. Mcdermott advises dbv technologies in connection with its. The company stated in a press release that the viaskin peanut dbv technologies patch delivers biologically active compounds to the immune system through intact skin. The condensation chamber formed between the skin and the center of the patch creates hydration of the skin and an accumulation of water.
Viaskin peanut is the companys lead product candidate designed to potentially. Montrouge, france, march 16, 2020 dbv technologies provides update on viaskin peanut bla for children ages 411 years conference call today, march 16, at 5. Dbv technologies peanutallergy patch phase 2b data. Biopharmaceutical food allergy treatments dbv technologies.
Dbv technologies provides update on viaskin peanut bla for children ages 411 years. Dbv is the biopharmaceutical company that is developing a topical patch treatment for allergies. Dbv tech down 45% premarket on hiccup with viaskin peanut. Its now set to enter phase iii trials by the end of this year, indicating the drug is far along in the testing stages.
Skin patch to treat peanut allergy shows benefit in. The peanut patch spokin the easiest way to manage food. Viaskin peanut patch resubmitted to the fda hcplive. Viaskin peanut allergy treatment pipeline dbv technologies. Dbv is also investigating the potential of this form of viaskin patch therapy for milk and egg allergies. Peanut allergy drug slated for 2018 debut cnnmoney. Fda accepts application for viaskin peanut patch for. Josh mandelbaum has worn the dbv viaskin peanut patch for five years. Two phase iii longterm studies in children ages four to 11 are ongoing.
417 313 1021 523 852 732 1391 412 629 465 961 910 1284 111 839 1153 306 168 1433 1119 1480 709 427 1372 1034 689 340 688 1439 1163 1236 927 335 712 504 1114 140 567 709 153 859