The FDA will vote on whether or not to approve a new treatment that aims to protect people against severe peanut allergy on Sept. 13, STAT reported.
The treatment, called AR101, was developed by biopharma company Aimmune Therapeutics. If approved, AR101 will be the first protective therapy for peanut allergy and the start of what Aimmune hopes will be a family of products designed to benefit people suffering from life-threatening food allergies, STAT wrote.
Six things to know about AR101 before next week's FDA decision:
1. AR101 is not a cure for a peanut allergy. It seeks to provide severe peanut allergy sufferers with protection against accidental exposure.
2. It's predicted to be very profitable. Analysts forecast peak sales of AR101 to exceed $1 billion annually, according to STAT’s article.
3. How the drug works. AR101 is a capsule filled with a measured quantity of peanut flour that can be mixed into food. The treatment works by exposing people to small, escalating doses of ingestible peanut protein over time with the goal of desensitizing them enough to prevent severe reactions.
4. AR101 was highly effective in clinical trials. Sixty-seven percent of the participants were able to tolerate the 600 milligrams of peanut protein after one year of treatment. In comparison, only 4 percent of those in the control group with a placebo pill were able to tolerate 600 milligrams of the treatment, according to STAT. Half of AR101 participants tolerated a 1,000-milligram dose of peanut protein after the year-long treatment, compared to 2.4 percent of placebo participants.
5. The concerns about AR101. During the one-year trial and maintenance period, 20 percent of people discontinued AR101, including 11 percent due to adverse events, such as one case of severe anaphylaxis. This person recovered with an epinephrine injection, but the incident raised concerns that AR101, if not administered carefully, could cause a fatal allergic reaction.
6. What the FDA panel will consider. The FDA is not likely to raise major concerns or questions about the efficacy of AR101 during the meeting due to the success of the clinical trials, STAT said. However, the safety and tolerability of AR101 will likely garner a lot of attention during the meeting. The FDA will have to consider if purposely exposing people with severe peanut allergies to peanut protein is justified or if it is too risky. The FDA might suggest restricting AR101 or saddling the label with significant safety warnings or patient monitoring requirements in order to minimize side effects or risks of severe anaphylaxis during treatment.
Read the full report here.