The FDA can’t directly control the price of EpiPen, but what it can do is approve competitors faster. Now, it's awarded a fast-track designation to Astellas’ DNA vaccine candidate for peanut allergies.
Japan's Astellas and partner Immunomic Therapeutics said the FDA granted the designation for the candidate, ASP0892, a new DNA vaccine based on the LAMP-Vax platform. The vaccine is designed to mitigate severe hypersensitivity reactions due to peanut allergy.
"Such designations reinforce the urgency of accelerating development programs for new treatments in these types of potentially life-threatening allergies,” Dr. Bernhardt Zeiher, president of development at Astellas, said in a statement.
According to a 2011 study, about 1.4% of children in the U.S. are allergic to peanuts, Astellas said, while the rate in adults is 0.6%. Even a small exposure to peanuts can cause those allergic to have a severe or even life-threatening reaction when eaten accidentally.
There is no approved method for preventing peanut-induced allergic reactions. Patients currently have to deal with their allergies by staying away from allergens and carrying epinephrine autoinjectors such as an EpiPen just in case. But as Mylan has in recent years infamously pushed up prices of that product, it has become even harder for patients to manage their severe allergies.
Astellas purchased exclusive worldwide rights to the use of Immunomic’s LAMP-Vax platform with $300 million upfront back in October 2015. The companies are also collaborating on a vaccine to treat allergies induced by Japanese red cedar pollen.
Even with a fast-track designation, Astellas trails California-based Aimmune Therapeutics, which already moved its peanut allergy therapeutic vaccine candidate AR101 into phase 3, the results of which are expected in the second half of 2017. Astellas' vaccine is in a phase 1 study testing its safety and immune response in adults who are allergic to peanuts.