Teva Will Try Again To Get FDA Approval On Epipen Competitor, By 2018

The price of the EpiPen emergency allergy medication soared by 400% to 600% over the last decade, in part due to a lack of competition. In February, the FDA rejected a potential competing injector from Teva Pharmaceuticals, but now the company says it still hopes to get an EpiPen alternative in pharmacies — at some point in the next two years. 

Reuters reports that Teva has not abandoned plans to release an epinephrine injector, and hopes to receive FDA approval by late 2017 or early 2018.

This is in keeping with what the company revealed in a February regulatory filing, where it disclosed that the FDA had rejected Teva’s application for “major deficiencies.” At the time, the company would only say that the product “will be significantly delayed and that any launch will not take place before 2017.”

According to the Pittsburgh Post-Gazette, the FDA did not initially follow up with Teva about the rejection, but in the wake of the recent news storm about the prices for EpiPen, both parties seem to have a new sense of urgency.

Sigurdur Olaffson, head of global generic medicines for Teva, told investors last week that it had requested a meeting with regulators after the application was flagged but hadn’t heard back until recently.

“The FDA has come back to us and we will have a meeting with them very, very quickly,” Olafsson said. “I think everybody understands that there is an opportunity. We are working with the FDA on a path forward.”

Still, if Teva receives approval for the drug by late 2017, it wouldn’t actually hit the market until sometime in 2018, at the earliest.

Analysts tell Reuters that the product, if a sold for less than the current EpiPen, could quickly capture a chunk of EpiPen’s 94% market share.

If the drug is approved, it would be one of few competitors for the EpiPen.

One of the few similar options available to treat anaphylaxis is Adrenaclick. However, that drug can be difficult to find, and you would likely need to have your doctor write the prescription specifically for that brand.

Amid increased scrutiny and backlash over the steep price increases, Mylan announced last month that it would sell a generic version of its drug, but that will still cost $300.

The company previously offered a $300 coupon for customers who purchase the $600 two-pack of EpiPens.

Teva says hoping to launch EpiPen-like device by 2018 in U.S. [Reuters]
Teva to meet with FDA on problems with generic EpiPen [Pittsburgh Post-Gazette]