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Patch To Treat Peanut Allergies To Get Expedited FDA Review

Patch To Treat Peanut Allergies To Get Expedited FDA Review

By Jonel Aleccia, The Seattle Times (TNS)

SEATTLE — A medical skin patch tested by Seattle-area doctors and families to treat dangerous peanut allergies in children will receive accelerated regulatory review, officials said Thursday.

The Viaskin Peanut patch made by the French biotech firm DBV Technologies was granted a breakthrough therapy designation by the federal Food and Drug Administration.

That status is granted to expedite development and review of drugs or biological products that demonstrate substantial improvement over other therapies in treating serious or life-threatening diseases or conditions. Further study is pending before the FDA’s final review.

In the case of the Viaskin patch, it’s the first breakthrough designation aimed at a drug to treat food allergies, which affect about 15 million people in the U.S., company officials said.

The new status was based on the results of a recent Phase IIb multicenter clinical trial that showed that the immunotherapy patch boosted the amount of peanut protein it took to elicit an allergic reaction by at least tenfold, particularly in children younger than 12.

Dr. James Tilles, a physician partner at Northwest Asthma & Allergy Center in Seattle, oversaw the study in 11 area participants. He works with the Seattle Food Allergy Consortium, or SeaFAC, which works to bring allergy-related clinical trials to the area.

“To me, the significance is that the FDA is encouraged that there may be an approved treatment for peanut allergy in the near future and they don’t want to have logistical hurdles get in the way,” Tilles said.

The latest trial tested the safety and effectiveness of the adhesive patches infused with doses of 50 micrograms, 100 micrograms or 250 micrograms of peanut protein. The patches work by administering small amounts of peanut protein in the outer layers of the skin, activating an immune response, but without releasing antigens into the bloodstream, where they can trigger allergic shock.

It’s a new kind of treatment that potentially poses fewer challenges and dangers than allergy shots or oral immunotherapy, which are now available.

The 250-microgram patch was the most effective, the study found, with more than half the children ages six to eleven responding to the medication.

DBV Technologies is preparing to launch a Phase III clinical trial in children, the last step before the product will be submitted to the FDA for review.

If all goes well, the peanut patch could be commercially available by 2018, Tilles said.

Photo: U.S. Department Of Agriculture via Flickr

U.S. Study: No Need To Avoid Peanuts While Pregnant

U.S. Study: No Need To Avoid Peanuts While Pregnant

Washington (AFP) – Women who eat peanuts while pregnant are less likely to have children with peanut allergies than women who avoid them, said a U.S. study out Monday.

The findings in the Journal of the American Medical Association (JAMA) Pediatrics were based on a study of more than 8,200 U.S. children.

Among those, researchers found 140 cases of children who were allergic to nuts.

When they looked into the mothers’ diets during and soon after pregnancy, as reported in the Nurses Health Survey II, they found that women who ate five or more servings per week of peanuts or tree nuts, such as cashews, almonds and walnuts, were far less likely to have children who were allergic than women who avoided nuts.

“Our study showed increased peanut consumption by pregnant mothers who weren’t nut allergic was associated with lower risk of peanut allergy in their offspring,” said senior author Michael Young of the Boston Children’s Hospital Division of Allergy and Immunology.

“Assuming she isn’t allergic to peanuts, there’s no reason for a woman to avoid peanuts during pregnancy.”

Doctors used to recommend that women steer clear of peanuts while pregnant and nursing, out of concern they might lead to allergies in children.

The United States recently saw a tripling of peanut allergies in children, going from 0.4 percent of young people in 1997 to 1.4 percent in 2010, according to background data in the JAMA article.

Allergies arise when the body treats nuts as a harmful invader. Symptoms can be severe and even fatal, causing hives, rashes, swelling, difficulty breathing and a swift drop in blood pressure.

But recommendations changed in 2008, when the American Academy of Pediatrics decided there was not enough evidence to continue urging women to avoid nuts in pregnancy.

Subsequent studies, like the latest one in JAMA, have shown that exposure is more likely to be helpful than harmful, though some confusion remains among the general public on the issue.

“Our study supports the hypothesis that early allergen exposure increases the likelihood of tolerance and thereby lowers the risk of childhood food allergy,” said the JAMA article.

Young noted that researchers cannot say that eating more peanuts in pregnancy will prevent peanut allergy in children.

“But we can say that peanut consumption during pregnancy doesn’t cause peanut allergy in children,” he said.

Photo: Saul Loeb via AFP