The results of a new study may lead to FDA approval of a new treatment that reduces the risk of potentially deadly reactions to peanut allergies
- Published On January 3, 2020
For people with allergic reactions to peanuts, anything they eat is a potential cause for serious concern. Even the smallest amounts of exposure can end up with hospitalization. As it stands, data shows that some 1.6 million kids in the US have a peanut allergy. Most allergies have some preventive medication, which is why medical experts have been researching ways to develop something similar for peanuts.
Fortunately, there is one such study that has shown such promise to the extent of receiving strong backing from the Allergenic Products Advisory Committee. The drug is called Palforzia (or AR101) developed by Aimmune. The treatment works by reducing the severity of allergic reactions after someone is exposed to peanuts.
Food and Drug Administration (FDA) approval
Despite the success of the new treatment, Palforzia is still subject to approval by the FDA before it can hit the market. However, the support from the Allergenic Products Advisory Committee could be crucial in the decision. The committee already voted strongly in favor of the drug in the later stages of 2019. The FDA does not have to stick to the committee’s vote, but, typically, it does not vote that differently. In turn, this has set up the treatment as the first peanut allergy drug in the USA after the FDA decides in 2020.
The treatment does not work on everyone
Unfortunately, the treatment has its setbacks, as shown by its most promising study yet. In the study, the drug worked on only two-thirds (around 60%) of the test subjects. Also, almost all the children experienced some adverse reactions, with the common ones being vomiting, throat irritations, nausea, coughing, itching skin, and gastrointestinal pain. A few children had severe allergic reactions that required the need for epinephrine. Almost 12% could not handle the therapy and dropped out.
For the above reasons, it is impossible to determine who drug may not work for. At best, the drug is likely to show promise on most people after prolonged treatment. Also, the therapy requires one to be on it for at least a year for it to be effective, which is time-consuming and potentially costly. Lastly, some have argued that the people who conducted the study had affiliations to Aimmune Therapeutics, which calls the authenticity of the study in question. As it stands, all eyes are on the FDA.