When Auvi-Q epinephrine auto-injectors return to store shelves early next year, Eric Edwards will breathe a sigh of relief.
It’s not just because he is vice president of product strategy for Kaleo, the company that develops the device used to treat severe allergic reactions, including anaphylaxis.
It’s also not just because Edwards and his twin brother, Evan, invented Auvi-Q.
It’s primarily because Edwards, his brother, and his three children all have serious food allergies and need to have an auto-injector with them at all times.
So, Edwards said, it hurt him greatly when the Auvi-Q product was voluntarily recalled a year ago, and he was forced to buy the device made by his company’s main competitor.
“I was devastated when I had to purchase an EpiPen,” Edwards told Healthline.
That will change next year when the new Auvi-Q auto-injector returns.
However, it’s still uncertain whether consumers will trust Auvi-Q products again after the recall.
“I think the [allergy] community is cautiously optimistic,” Tonya Winders, president and chief executive officer of the nonprofit Allergy & Asthma Network.
Returning after the recall
Sanofi, the previous distributor of Auvi-Q, announced its voluntary recall of the auto-injectors in October 2015.
In February, Sanofi announced it was ending its licensing agreement for Auvi-Q and returning U.S. rights to the product back to Kaleo.
The recall was voluntarily issued because a small number of devices were found to potentially have inaccurate dosage delivery, which may have included failure to deliver the drugs to users.
Epinephrine helps to relax muscles, open airways, and reduce swelling during a severe allergy attack.
Spencer Williamson, president and chief executive officer for Kaleo, told Healthline the recall involved a small number of devices, but it was ordered because of the serious consequences involved.
He said Kaleo has introduced a 100 percent robotic manufacturing system with more than 100 quality checks.
“We are confident we can deliver the highest quality product,” Williamson said.
Edwards said he has a personal stake in the product being safe and dependable. He might have to use it on himself or one of his children.
“I have a commitment to a quality product,” he said.
The Auvi-Q auto-injectors will be introduced sometime during the first half of 2017. Company officials have not said yet what the price will be.
Williamson said more details will be unveiled as the Auvi-Q return gets closer.
Price will be important
The price of an EpiPen was $100 in 2009.
It rose sharply last year after the Auvi-Q recall to $600 for a two-pack. That prompted a congressional hearing in which Mylan’s chief executive officer was called to testify about the leap in price for her company’s epinephrine auto-injector.
Officials at Mylan did not respond to Healthline’s request for an interview for this story.
Both Edwards and Williamson said the price controversy shows the need for choices when it comes to lifesaving devices.
“We saw this summer what happens when there are no options out there,” said Edwards.
The Kaleo executives avoided direct criticism of Mylan, but it was clear they feel consumers were taken advantage of.
“Sometimes companies lose sight of what this is all about,” said Williamson. “It’s about healthcare and saving lives.”
Whether that translates into sales for Auvi-Q remains to be seen.
Winders say price will be a key component.
She said the EpiPen price hike produced a lot of anger in the allergy community.
However, in late August Mylan began offering a generic version of the EpiPen for $300.
Winders said that puts pressure on Kaleo to offer a competitive price when it reintroduces its product next year.
“It could provide a challenge for Auvi-Q,” she said.
Winders said healthcare providers will be an important factor, too. They will want data backing up Kaleo’s claims that the new Auvi-Q auto-injectors are safe before they start recommending them to their patients.
“People trust their providers. If the provider has confidence in the product, then they’ll have confidence,” she said.
Winders added that as a patient advocate she is happy that Auvi-Q will return soon.
“I’m excited for parents to have more options,” she said. “It’s critically important that families have choices.”