Shifting fates in the competition to treat peanut allergy
The FDA has rejected a treatment for patients with severe peanut allergy developed by DBV Technologies, a small French biotech. The bad news was expected because the FDA had previously raised concerns about potential problems with the stickiness of the skin patch used to deliver the treatment. Regulators also cancelled — and never rescheduled — a planned advisory committee meeting to discuss the treatment.
Nevertheless, DBV may have a hard time recovering from the setback, which, in turn, would give a boost to its competitor Aimmune Therapeutics.
In its rejection letter, the FDA not only asked DBV to redesign the patch — work that was already underway — but it also asked for more data from a new clinical trial. The latter demand is particularly worrisome, analysts said, because it suggests the FDA has more deeply rooted problems with the efficacy of the patch than just a worry about it coming unglued from a patient’s skin. DBV could be looking at a multi-year delay depending on the scope of the clinical trial it needs to run.
That leaves the peanut allergy treatment market to Aimmune, which won approval for its treatment in January. But Aimmune is not exactly in a position to capitalize on its rival's misfortunes. The Covid-19 pandemic has shut down allergy doctor practices, and with it any opportunity for Aimmune to launch its treatment. Sales in the second quarter: Zero.
Nevertheless, DBV may have a hard time recovering from the setback, which, in turn, would give a boost to its competitor Aimmune Therapeutics.
In its rejection letter, the FDA not only asked DBV to redesign the patch — work that was already underway — but it also asked for more data from a new clinical trial. The latter demand is particularly worrisome, analysts said, because it suggests the FDA has more deeply rooted problems with the efficacy of the patch than just a worry about it coming unglued from a patient’s skin. DBV could be looking at a multi-year delay depending on the scope of the clinical trial it needs to run.
That leaves the peanut allergy treatment market to Aimmune, which won approval for its treatment in January. But Aimmune is not exactly in a position to capitalize on its rival's misfortunes. The Covid-19 pandemic has shut down allergy doctor practices, and with it any opportunity for Aimmune to launch its treatment. Sales in the second quarter: Zero.
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