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Comparing Aimmune's (AIMT) Peanut Allergy Medication AR101 to DBV Technology's (DBVT) Viaskin Peanut As They Race for FDA ApprovalTicker(s): AIMT, DBVT
Name: Dr Jessica Savage - MD
Institution: Harvard University
- Assistant Professor of Medicine and Director of the Food Allergy Center and Director of Population Studies
- Principal investigator of a multidisciplinary research program focused on the environmental and genetic factors that influence the development of food allergy and underlie the recent rise in allergic disease
- Member of the National Institute of Environmental Health Sciences Center at the Harvard School of Public Health.
What do you do currently to help your patients with peanut allergies? What rescue therapies are used when patients are exposed to peanuts?
Last week AIMT released positive data from their Phase II ARC002 trial and DBVT released encouraging Phase IIb results from OLFUS-VIPES. Can you discuss the differences in how these trials were designed?Added By: pjloria
Can you discuss the differences in mechanism of action for AR101 and Viaskin?Added By: pjloria
Can you talk about any differences in dosing between the two drugs and how this could affect the number of doctors who prescribe each medication?Added By: pjloria
Given the current data, what are the differences in efficacy and safety between AR101 and Viaskin? Does either drug have an advantage in efficacy? Does either have an advantage in safety?Added By: pjloria
How do these differences in safety and efficacy change your expectations on how many doctors will be prescribing each drug?Added By: pjloria
Given the current data on both drugs, are they likely to reach FDA approval? Does either drug have a better chance of being approved by the FDA than the other?Added By: pjloria
Assuming they both get approved, what percentage of existing patients will be prescribed AR101 and Viaskin respectively? What percentage of new patients will be prescribed AR101 and Viaskin respectively?Added By: pjloria
Is either drug better fit for a particular patient subset? i.e pediatric vs. adult patientsAdded By: pjloria
How does the projected cost of AR101 compare to the projected cost of Viaskin? At what point does price become the deciding factor in choosing AR101 or Viaskin?Added By: pjloria
Does "epicutaneous immunotherapy" by Viaskin patch create any lifestyle issues for children that might limit use in the real world? For example, do children have to forgo swimming while on treatment?
The study published last year (March 2015) in the NEJM showed a big benefit of introducing peanut protein starting infancy, with significant reduction in development of peanut allergy later on vs the control group who avoided peanuts http://www.nejm.org/doi/full/10.1056/NEJMoa1414850 . If the current practice of peanut avoidance during infancy reverses, will we see less need for these desensitizing products like AR101 & Viaskin over time? In response to this NEJM published study, do you think there is a need for a peanut protein formula product like the one offered by Antera Therapeutics or can parents just mix a small amount of peanut butter into their children's food?
Which company do you feel has the better product development pipeline for individuals with multiple food allergies?Added By: userfb321dd2
If a child begins treatment for peanut allergy, will they continue to need treatment for as long as the allergy exists? How often would be refills and overall what is the duration of treatment?Added By: userfb321dd2
What do the trials and research mean for the development of medicine for other common allergies such as Wheat, Egg, and Dairy. Do you think FDA Approval for peanut would mean treatments of other allergens would also be approved?Added By: userfb321dd2
Are there safety and legal concerns for not following the full dosage and will this be a larger problem. For example, a child that does not ingest the full dose of AR101 or a kid that removes the Viaskin Patch from their skin.Added By: userfb321dd2
Do you think either product will lead to a cure for peanut allergy? If so, which product do you think has the better chance of being successful in curing peanut allergy for most individuals?Added By: userfb321dd2
What is your perspective on alternative antigen delivery methods that have been investigated, such as sublingual drops, subcutaneous injections and toothpaste?Added By: subramony
What do you think is the most meaningful clinical endpoint for these studies (e.g. is a fold increase in tolerance more meaningful to you or is a specific threshold for desensitization more meaningful)? If it is a specific threshold, what do you think the appropriate threshold amount is?Added By: subramony
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- Phase 2 Extended Maintenance Data Supporting Safety and Tolerability Profile of AR101 for Peanut Allergy AIMT Occurred On: Jun 13, 2016
- Aimmune (AIMT) Announces Phase 2 ARC002 Data Evaluating AR101 in Treatment of Peanut Allergy AIMT Occurred On: Mar 06, 2016