EpiPen Rival to Return to U.S. Market in 2017

Auvi-Q device takes advantage of Mylan’s woes

Virginia-based Kaléo, Inc., has announced that it will reintroduce its Auvi-Q (epinephrine injection, USP) auto-injector to the U.S. market in the first half of 2017. Auvi-Q is a prescription medication used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions.

The company issued the following statement:

“Kaléo is aware of the epinephrine auto-injector access and affordability challenges confronting patients and is working to engage with various stakeholders, including wholesalers, insurance companies, pharmacies, and pharmacy benefit managers, to ensure that all patients, regardless of insurance coverage, have affordable access to Auvi-Q.”

The Auvi-Q device was recalled from the U.S. market last year amid concerns about the accuracy of the dosage delivered. French pharmaceutical company Sanofi had licensed and manufactured Auvi-Q, but it returned the rights to the product to Kaléo in February 2016 after the recall.

The device contains the same epinephrine drug that’s in Mylan Pharmaceuticals’ EpiPen. Mylan has come under fire from lawmakers and consumer groups for raising the list price for a pair of EpiPens to more than $600 this year from $100 in 2007, when Mylan acquired the product. The company said in September that it plans to launch, at a list price of $300, its own generic EpiPen by the end of the year.

Epinephrine is used to treat severe, life-threatening allergic reactions that occur as a result of exposure to allergens, including tree nuts, peanuts, milk, eggs, fish, shellfish, soy, wheat, insect bites, latex, and medications.

The Auvi-Q device includes a voice-prompt system that guides the user with step-by-step instructions through the epinephrine delivery process, and a needle that automatically retracts after administration.

Kaléo has declined to comment on a planned list price for the relaunched device.

Sources: Kaléo; October 26, 2016; and Reuters; October 26, 2016.