A new drug designed to minimize the incidence and severity of peanut related reactions in individuals between four and 17 years of age has been voted in favour by the US Food and Drug Administration (FDA) committee in approving a treatment to such allergies.
The FDA Allergenic Products Advisory Committee voted in favour of treatment by administrating Palforzia, which if approved will become the first FDA endorsed treatment for peanut allergy.
The agency, which frequently follows the lead of the advisory committee, will, however, make its final decision by January 2020 as to whether or not the drug could be approved to treat more than three million Americans allergic to peanuts.
"We are very pleased that the FDA committee has voted in support of Palforzia," CNN quoted CEO of drug manufacturer Aimmune Therapeutics, Jayson Dallas, as saying.
Palforzia works by exposing children to controlled dosages of peanut protein until they have developed a maintenance level for them.
The most severe adverse reactions of peanut exposure allergic people include anaphylaxis, a condition when the entire body responds with symptoms including impaired breathing, a sudden drop in blood pressure, fainting and dizziness. Anaphylaxis can be fatal if not treated immediately. Currently, allergic people exposed to peanut should inject epinephrine or antihistamines in case of milder reactions.
A phase 3 trial submitted as evidence in favour of the drug found two of three children being able to eat as many as two peanuts without any allergic symptoms after the treatment.
About 9 percent children dosed with Palforzia, however, had to stop the treatment during the trial because of severe allergic reactions, the company said, adding that the most common adverse effects were abdominal discomfort or pain, coughing, hives, itching, nausea, throat irritation and vomiting.
Is FDA always right?