Kaleo said today that despite ongoing manufacturing delays reported by epinephrine auto-injector manufacturers, Kaleo’s Auvi-Q device is available via prescription and that the privately-held company has ‘sufficient supply to meet any anticipated demand.’
Kaleo’s epinephrine auto-injector features voice instructions that guide users through the drug-delivery process and an auto-retractable needle system, according to the company.
“We understand how critically important it is for those affected by life-threatening allergies to be able to access an epinephrine auto-injector, especially as families prepare for the back to school season. Kaléo is able to fill, and is filling, all the Auvi-Q orders through our direct delivery service at www.auvi-q.com,” Phil Rackliffe, GM of Kaleo’s allergy & pediatrics unit, said in prepared remarks. “It’s important to note that patients must obtain Auvi-Q through the direct delivery service to ensure delivery to their home or healthcare provider’s office and the best expiration dating for Auvi-Q.”
Earlier this year, a survey from the advocacy group Food Allergy Research & Education found that hundreds of people across the U.S. have had trouble getting an Epipen.
Mylan (NSDQ:MYL), which distributes the emergency allergy auto-injector, reportedly told the FDA months ago that manufacturing delays experienced by its partner, Pfizer’s Meridian Medical Technologies, were straining its Epipen supply.
Updated 8/14 to reflect that Mylan does not make the Epipen device.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
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