Following the release of the medication lots by the
'We are pleased that peanut-allergic children are being treated with PALFORZIA just six weeks after its FDA approval. Our anticipation of and preparedness for the REMS program allowed for a swift and smooth implementation of those requirements. In addition, our
PALFORZIA may only be administered to patients by allergists and allergy practices that have been certified under the Risk Evaluation and Mitigation Strategy (REMS) program. A list of certified allergists who are able to provide PALFORZIA treatment may be viewed at www.PALFORZIAREMS.com.
PALFORZIA was approved by the
PALFORZIA is available only through a Risk Evaluation and Mitigation Strategy (REMS). Requirements of the REMS include: the prescribing physician and patient must be enrolled in the REMS prior to initiation of treatment; the initial dose escalation and the first dose of each up-dosing level must be administered in a certified healthcare setting; epinephrine must always be immediately available to patients and pharmacies/distributors must be certified with the REMS and dispense PALFORZIA only to certified healthcare settings or to patients who are enrolled in the REMS. Consistent with approved immunotherapies indicated to treat allergic conditions, the Prescribing Information for PALFORZIA contains a boxed warning.
Aimmune will provide resources to patients and families who, upon consultation with their physician, wish to seek treatment with PALFORZIA. These resources will include educational materials, a dedicated call center, a co-pay program for eligible patients, and a
About Aimmune
Forward-Looking Statements
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 commercial launch of PALFORZIA, including provision of information regarding safety and the REMS process; Aimmune's expectations regarding the provision of resources to patients and their families who wish to seek treatment with PALFORZIA and Aimmune's expectations regarding potential applications of the CODIT approach to treating 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; Aimmune's dependence on the success of PALFORZIA; Aimmune's ability to train and monitor its commercial field organization and distribution network; the degree of acceptance of PALFORZIA among physicians, patients, healthcare payors, patient advocacy groups and the general medical community; Aimmune's ability to obtain favorable coverage and reimbursement from third-party payors for PALFORZIA; Aimmune's reliance on third parties for the manufacture of PALFORZIA; Aimmune's ability to implement and comply with the REMS for PALFORZIA; possible regulatory developments in
This press release concerns PALFORZIA (AR101), which has been approved for marketing by the FDA in
Contact:
Tel: (650) 376-6492
Email: IR@aimmune.com
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