FDA to Assess First Drug Meant to Prevent Peanut Allergy
Palforzia is a capsule containing a pharmaceutical-grade dose of the peanut protein
FRIDAY, Sept. 13, 2019 (HealthDay News) -- A panel of experts at the U.S. Food and Drug Administration is set to weigh the pros and cons of what could be the first drug ever approved to prevent peanut allergy.
The medicine, called Palforzia, is a capsule containing a pharmaceutical-grade dose of the peanut protein. In one clinical trial, children who took Palforzia for a year were eventually able to tolerate the equivalent of two peanuts, the Washington Post reported. But the drug had a downside, too: an increase in allergic reactions plus the need for injections with epinephrine to ease those reactions.
In a trial involving 551 people, 496 of them children, about a tenth of people in the trial dropped out due to side effects such as allergic reactions, abdominal pain, or vomiting, the Post said. Fourteen percent of people who did have an allergic reaction needed to use an epinephrine pen to ease that reaction, twice as many as in the arm of the trial in which patients got a "dummy" placebo pill.
No one is calling Palforzia a cure for peanut allergy: Patients will still need to avoid peanuts and carry devices to treat an allergic reaction in an emergency. It is hoped, though, that Palforzia might help ease concerns about inadvertent exposure to peanut in small amounts. The drug's maker, Aimmune, is seeking FDA approval for children ages 4 to 17 years.