Aimmune Accelerates Commercial Planning For Peanut Allergy Drug
Even better than expected efficacy and safety in the Phase III PALISADE trial puts Aimmune on track to file its BLA for peanut protein capsule AR101 by the end of 2018.
You may also be interested in...
Aimmune CEO Jayson Dallas talked to Scrip about the company's field team, allergists' and payers' responses to the first food-derived medicine, and why Viaskin Peanut patch is not a competitive threat.
Aimmune’s oral immunotherapy seems destined to come to market with a strict REMS, though analysts do not expect this will impact adoption. DBV is awaiting word on whether the FDA will review its second attempt at a BLA submission for Viaskin Peanut.
Palforzia was associated with a higher rate of adverse events, systemic allergic reactions, eosinophilic esophagitis and epinephrine use in controlled clinical trials; Allergenic Products Advisory Committee will weigh approval for patients ages 4-17 years with confirmed peanut allergy diagnosis.