Promising immunotherapy drug to treat peanut allergies may be approved although 10% of study subjects had serious side effects


On [September 13], a panel of experts assembled by the Food and Drug Administration voted that the agency should approve a drug called Palforzia designed to help people manage their peanut allergy. But the non-unanimous verdict rendered by the panel highlights the ongoing debate over whether this therapy, a pill containing peanut protein, is actually worthwhile for patients to take.

The treatment is known as oral immunotherapy, and it works by purposefully exposing someone to a tiny amount of the allergen, with the hope that small doses given over a long enough time can desensitize the person’s hyperactive immune system.

Over 10 percent of people taking Palforzia discontinued the treatment, often because they couldn’t stand the side-effects they experienced. These side-effects included anaphylaxis.


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Outside researchers have documented these risks, seen across many clinical trials of peanut oral immunotherapy. And given that people are taking the treatment to avoid severe allergic reactions, some have argued that the risks might outweigh the benefits. It was that same rationale that led two of the nine voting experts to recommend against approving the drug.

Read full, original post: The First Peanut Allergy Drug Might Be Approved Soon—but Not Without Controversy

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