Aimmune Therapeutics, Inc. AIMT announced that the Allergenic Products Advisory Committee (APAC) convened by the FDA voted in favor of pipeline candidate, Palforzia.
The committee supported the use of Palforzia in children and teens with peanut allergy. The APAC voted in favor of the candidate’s effectiveness in the ratio of 7 to 2. The committee also voted in the ratio of 8 to 1 in favor of the safety data in conjunction with additional safeguards, which are adequate to support the use of Palforzia.
We note that Palforzia, the proposed trade name of AR101, is a complex, biologic oral immunotherapy (OIT) candidate, which is designed to reduce the incidence and severity of allergic reactions. These include anaphylaxis after the accidental exposure to peanut in patients aged 4-17 years with a confirmed diagnosis of peanut allergy.
Aimmune’s Biologics License Application (BLA) seeking approval for Palforzia for the treatment of children and adolescents with peanut allergy is currently under FDA review, with an action date in late January 2020. The BLA was submitted in December 2018. The agency had earlier granted the Fast Track and the Breakthrough Therapy designations to the candidate. Additionally, the European Medicines Agency (EMA) is also reviewing the company’s Marketing Authorization Application (MAA) for the same. Both agencies have conditionally accepted Palforzia as the trade name for AR101.
As part of its original BLA submission, Aimmune has proposed a number of risk-management measures in line with the recent Advisory Committee discussion — the requirement for the initial dose escalation and first dose of each dose-escalation level to be administered in a facility equipped to treat systemic allergic reactions, documentation of patients having a prescription for injectable epinephrine prior to the initiation of Palforzia, distribution of therapy through specialty pharmacies, and a purposefully-designed packaging such that patients only receive their appropriate dose. Moreover, the company proposed a Black Box warning in the product labeling in the original BLA submission, consistent with immunotherapies indicated to treat allergic conditions.
Trading was halted on Sep 13, owing to the scheduled meeting of APAC. Shares of Aimmune gained in after-hours trading. Meanwhile, shares of the company have gained 3.1% so far this year against the industry’s decline of 1.7%.
A potential approval will boost the growth prospects of this clinical-stage biopharmaceutical company. Peanut allergy is one of the most common food allergies, which affects more than 1.6 million children and teens in the United States alone.
The candidate is also being evaluated in combination with Sanofi’s SNY dupilumab in a phase II study for treating peanut allergy. The study was sponsored by Sanofi’s partner Regeneron REGN.
Apart from Palforzia, Aimmune is also evaluating its second investigational, complex biologic product, AR201, for the treatment of egg allergy. The study was initiated in August 2019. The company is exploring another product candidate to treat multi-tree nut allergy.
Zacks Rank & A Stock to Consider
Aimmune currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Amgen AMGN, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Amgen’s earnings per share estimates have increased from $13.89 to $14.30 for 2019, and from $14.72 to $15.42 for 2020, in the past 60 days.
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