The FDA has approved the first treatment for peanut allergies, Aimmune Therapeutics' drug called Palforzia.
Palforzia, approved Jan. 31, is designed to treat peanut allergies by exposing patients to small amounts of peanut powder.
Patients are started with a small dose of peanut powder, then gradually given higher doses for several months. Once they reach the highest level they can tolerate, they take that dose indefinitely to maintain a resistance against peanut powder.
Palforzia is a capsule containing precise doses of peanut powder that patients break and mix into food. It's designed for children ages 4 to 17.
Peanut allergies affect about 1 million U.S. children, and only a fifth of them outgrow the allergy as they get older, according to Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.
In a clinical trial, about 67 percent of children who took Palforzia were able to tolerate at least two peanuts without having significant allergic symptoms, compared to 4 percent who received a placebo.
Aimmune clarified that Palforzia isn't intended to allow patients to eat peanuts, but to reduce the risk of reactions if a patient is accidentally exposed to peanuts. Patients are still advised to avoid peanuts and carry EpiPens.
Palforzia will cost $890 a month, or $10,680 a year, The Wall Street Journal reported. Roth Capital Research analyst Zegbeh Jallah told the Journal Palforzia will likely generate annual sales of $1 billion by 2026.
However, critics worry the risk of severe allergic reactions associated with Palforzia aren't worth it. The Institute for Clinical and Economic Review said in a report released last July that Palforiza's overall health benefits aren't better than simply avoiding peanuts, STAT reported. The risk of serious allergic reactions if the drug is not administered properly has worried some allergists and physicians.
Read the full news release here.