Company decision makes it uncertain when the epinephrine injector for life-threatening anaphylaxis reactions will return to store shelves.
Sanofi executives have announced their company is ending its license and development agreement for the auto-injector Auvi-Q.
In a press release, Sanofi officials said the agreement with kaléo, Inc., formerly Intelliject Inc., would terminate later this year.
The release stated all United States and Canadian rights for Auvi-Q would return to kaléo and the Virginia-based company will decide when the product will return.
The product has been off store shelves in the U.S. since October. That’s when Sanofi issued a voluntary recall of Auvi-Q after receiving reports the auto-injector was delivering inaccurate doses to some patients.
In an email to Healthline, Sanofi officials said the recall was not a factor in their decision to end the agreement.
“Sanofi’s ongoing transformation to focus on critical therapeutic areas is the reason for the decision,” the email statement read.
Sanofi officials also referred all questions on Auvi-Q’s return to market to kaléo.
In an email to Healthline, kaléo officials said they are studying the situation.
“Sanofi is in discussions with kaléo on these terms and for an orderly transition plan. kaléo will evaluate timing and options for bringing Auvi-Q back to market,” the statement read.
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Auvi-Q is an epinephrine auto-injector used to treat life-threatening allergic reactions such as anaphylaxis in people who have a history of these reactions.
It was one of three epinephrine auto-injectors available in the U.S.
Dr. James R. Baker, Jr., the chief executive officer and chief medical officer for Food Allergy Research & Education (FARE), said allergy patients now have limited options for these life-saving machines.
“There is an overall need for more options on the market from which patients can choose,” Baker said in an email to Healthline.
He added his organization will keep a close eye on the situation.
“We have heard from many in the food allergy community that this decreases their choices for treatment of reactions,” Baker said. “[We] will closely monitor developments concerning the potential by kaléo to bring this auto-injector back to market and work to ensure that the patient community’s voice is part of their evaluation.”
The news of Sanofi ending its agreement lit up some social media sites.
On one Facebook page, commenters lamented the continued loss of Auvi-Q and also criticized Sanofi for letting it happen.
Amanda Carey wrote: “So disappointing! When they first came out I was ecstatic to have a reliable rescue med small enough to keep in my pocket or clutch!”
Cm Rogers added: “That sucks. I carry this one because it is convenient. I don’t carry the epipen because it is not convenient.”
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