KalÃ©o Re-Launches Epinephrine Auto-Injector
Kaléo, a privately held pharmaceutical company headquartered in Richmond, Virginia, has said it will reintroduce its Auvi-Q (epinephrine injection, USP) auto-injector, for treating severe allergic reactions, to the US market in the first half of 2017. The re-launch comes a year after Auvi-Q was voluntarily pulled from the markets in the US and Canada by Sanofi and Kaléo regained the rights to its product. Auvi-Q was recalled because it was found to potentially have inaccurate dosage delivery, which may have included failure to deliver the drug.
At the time that Sanofi decided to do the voluntary recall in October 2015, it also decided to return all US and Canadian rights of the product to the developer, Sanofi stated in its 2015 Form 20-F annual report.
The recall involved all Auvi-Q currently on the market at that time and included both the 0.15-mg and 0.3-mg strengths for hospitals, retailers, and consumers. This included lot numbers 2081278 through 3037230, with expiration dates of October 2015 through December 2016.
Auvi-Q is a compact epinephrine auto-injector with features that include a voice prompt system to guide users through setup and the delivery process. After regaining the rights to AuviI-Q, Kaléo conducted a manufacturing assessment and invested in new technology and quality systems for delivery of the product.
Kaléo said it is aware of the epinephrine auto-injector access and affordability challenges confronting patients and is working to engage with stakeholders, including wholesalers, insurance companies, pharmacies, and pharmacy benefit managers, to ensure affordable access to Auvi-Q.
Meanwhile, Mylan said in August 2016 that it expects to launch its authorized generic version to its EpiPen Auto-Injector (epinephrine injection, USP), pending completion of labeling revisions. The product will be sold at a list price of $300 per two-pack carton, which represents a-more-than 50% discount to the Mylan list price, or wholesale acquisition cost of the branded medicine, the company said at the time. Kaléo’s Auvi-Q is a competitor to Mylan’s authorized generic as well as the branded EpiPen.
Mylan’s authorized generic will be identical to the branded product, including device functionality and drug formulation. Upon launch, the product will be available as a two-pack carton in both 0.15-mg and 0.30-mg strengths. Mylan also intends to continue to market and distribute branded EpiPen.
Mylan announced its generic product launch following an earlier announcement by the company of making pricing adjustments for EpiPen in the wake of several US senators calling for pricing reform for the product.