FDA Allergenic Products Advisory Committee Votes to Support the Use of Aimmune’s PALFORZIA™ (AR101) for Peanut Allergy
The APAC voted 7 to 2 that the efficacy data and 8 to 1 that the safety data, in conjunction with additional safeguards, are adequate to support the use of PALFORZIA.
Peanut allergy is one of the most common food allergies, affecting more than 1.6 million children and teens in the U.S.i It can be a chronic and life-long condition, and reactions to peanut are severe and potentially life-threatening.ii For peanut-allergic individuals, the threat of a severe reaction interferes with their quality of life and has a daily effect on their families.
“We are very pleased that APAC voted in favor of PALFORZIA. This is an important day for the children, teens and their families who live with the profound daily impact of peanut allergy. We look forward to continuing to work with the
As part of Aimmune’s original Biologics License Application (BLA) submission, the Company proposed a number of risk management measures in line with today’s Advisory Committee discussion which include: the requirement that the initial dose escalation and first dose of each dose-escalation level be administered in a facility equipped to treat systemic allergic reactions; documentation that patients have a prescription for injectable epinephrine prior to initiation of PALFORZIA; distribution of therapy through specialty pharmacies; and purposefully designed packaging so patients only receive their appropriate dose. Consistent with immunotherapies indicated to treat allergic conditions, Aimmune also proposed a Black Box warning within the product labeling in the original BLA submission.
“Patient safety has been central to us since the beginning of the PALFORZIA development program. We are gratified to be aligned with
Aimmune’s BLA seeking approval for PALFORZIA for the treatment of children and adolescents with peanut allergy currently is under review by the
The BLA includes extensive clinical data from the largest and only phase 3 clinical trials to meet their primary endpoints in children and teens with peanut allergy, with over 1,000 patients enrolled. The results demonstrated that PALFORZIA treatment resulted in a significant increase in the amount of peanut protein tolerated compared to placebo, and that PALFORZIA-treated patients could expect fewer and less severe reactions to accidental peanut exposures, compared to placebo-treated patients, and significantly reduces the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure to peanut.
PALFORZIA™ is an investigational, peanut-derived, biologic drug candidate for use in oral immunotherapy in patients with peanut allergy. The drug candidate, which is manufactured in accordance with current Good Manufacturing Practices (cGMP), delivers a daily dose of peanut protein with a consistent protein profile, analyzed to ensure reliable major allergen content. The amount of active ingredient in each PALFORZIA capsule is controlled to ensure minimal variability of allergen content across doses of a given strength. PALFORZIA is administered as an oral powder in graduated doses in pull-apart capsules or foil-laminate sachets. The contents are mixed thoroughly with a few spoonfuls of age-appropriate, unheated food of the patient’s choice.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmune’s expectations regarding the potential benefits of PALFORZIA; Aimmune’s expectations regarding the timing of potential approval of the BLA for PALFORZIA; Aimmune’s expectations regarding the potential risk management measures for PALFORZIA; and Aimmune’s expectations regarding potential applications of the CODIT™ approach to treating potentially life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will need additional funds to finance its operations; the unpredictability of the regulatory process; the possibility that Aimmune’s or any of its collaborative partners’ clinical trials will not be successful; Aimmune’s dependence on the success of PALFORZIA; Aimmune’s reliance on third parties for the manufacture of Aimmune’s product candidates; possible regulatory developments in
This press release concerns AR101 and AR201, product candidates that are under clinical investigation. Neither AR101 nor AR201 has been approved for marketing by the
PALFORZIA™ is a trademark of
i Aimmune market research.
Jerica Pitts (onsite)