Aimmune Therapeutics' peanut allergy treatment, Palforzia, has passed the FDA's advisory committee review. The committee voted 7 to 2 in favor of the drug's effectiveness and 8 to 1 on safety but concerns about the drug’s effectiveness remain.
In clinical testing, this oral immunotherapy outperformed placebo but users also relied on epinephrine injections, like EpiPen, twice as often as those taking placebo. Also, due to the way the study was designed, it remains unclear if this drug will actually reduce the incidence and severity of allergic reactions caused by peanut exposure.
Palforzia is an oral capsule consisting of “pharmaceutical-grade” peanut powder that needs to be taken daily along with food. While that seems simple enough, the committee discussed the need for a Risk Evaluation and Mitigation Strategies (REMS) plan. Since Palforzia can actually trigger an allergic reaction, a patient willing to take this medication would need to attest to carry epinephrine everywhere they go and agree to limit dose escalation to only certified facilities. The proposed labeling would also likely include warnings about avoiding hot showers or exercise in the hours after dosing to reduce the risk of a reaction.
Aimmune Therapeutics' has not announced the price for Palforzia yet, but it has been suggested that the list price could possibly be as high as $20,000. The first 6 months of therapy are expected to cost between $5,000 and $10,000 followed by $400 per month after that. With peanut allergy cases becoming more and more prevalent combined with the Palforzia price estimates (+ EpiPen add-on treatment costs), monitoring impact on pharmacy spend could be a hard nut to crack.