The Food and Drug Administration has accepted for review the Biologics License Application for AR101 (Aimmune Therapeutics) to reduce the risk of anaphylaxis following accidental exposure to peanut.
PVX108, a peptide-based immunotherapy in development for the treatment of peanut allergy, demonstrated a favorable safety profile.
Peanut oral immunotherapy can be a safe and effective treatment for most patients with a peanut allergy, although side effects are common.
The Food and Drug Administration (FDA) has granted Fast Track status to ARS-1 (ARS Pharmaceuticals), an investigational intranasal epinephrine spray being developed to treat severe allergic reactions, including anaphylaxis.
The patient had a history of asthma, COPD, diabetes and severe anaphylactic reactions to multiple medicines.
Research has shown that ≥95% of the 32 million people in the United States with a documented penicillin allergy are ultimately able to tolerate this class of medications.
To investigate the incidence of anaphylaxis after vaccination, study authors reviewed data submitted to the Vaccine Adverse Event Reporting System (VAERS) between 1990 and 2016.
The product will be made available first in institutions followed by a launch in the retail setting.
In order to determine the effect of heat exposure on the concentration of adrenaline in EAIs, the study authors placed nine 0.3mg EpiPen Senior EAIs inside a parked car from 8:30 AM until 8:30 PM on a summer day.
The generic version of the EpiPen Jr (epinephrine injection, USP) 0.15mg as well as additional supply of the generic version of the EpiPen Auto-Injector 0.3mg will be made available in 2019.
