First Generic Epinephrine Auto-injector Approved by FDA

The FDA has approved the first generic epinephrine auto-injector for the emergency treatment of allergic reactions, including anaphylaxis. Teva Pharmaceuticals' approved product, 0.3 mg and 0.15 mg strengths generic versions of EpiPen and EpiPen Jr, is indicated for adults and pediatric patients who weigh more than 33 pounds.

“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe, and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.

Life-threatening allergies can include reactions to insect bites or stings, foods, medications, latex, or other causes. Anaphylaxis is a medical emergency that affects the whole body and, in some cases, leads to death. Anaphylaxis occurs in approximately 1 in 50 Americans. Patients who have had an anaphylaxis episode always face the risk of another one. Because of this risk, they must carry an emergency dose of epinephrine at all times. Many must keep more than one dose at hand.

In a statement toPharmacy Times, Lisa Gable, CEO of Food Allergy Research & Education (FARE), a national advocacy organization, applauded the FDA's decision to approve Teva Pharmaceuticals' generic product. “For far too long, families managing food allergies have struggled to afford epinephrine auto-injectors, or even to fill their prescriptions given the current national shortage," Gable said in the statement. "Food Allergy Research & Education has long called for increased competition in the marketplace to improve affordability."

This epinephrine injection is intended for immediate administration to patients. When given intramuscularly or subcutaneously, it has a rapid onset and short duration of action. Epinephrine works by reducing swelling in the airway and increasing blood flow in the veins.

The most common adverse effects associated with epinephrine injection are anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. Rare cases of serious skin and soft tissue infections have been reported following use of the drug. In patients with heart disease, use of epinephrine injection may cause chest pain or abnormal heart beats. Following use of epinephrine injection, patients should seek immediate medical or hospital care.

Epinephrine auto-injector are intended to automatically inject a dose of epinephrine into a person’s thigh to stop an allergic reaction. The FDA has approved several epinephrine auto-injector products under new drug applications to treat anaphylaxis, including EpiPen, Adrenaclick and Auvi-Q. In addition, “authorized generic” versions of EpiPen and Adrenaclick are marketed without the brand names. An authorized generic is made under the brand name’s existing new drug application using the same formulation, process, and manufacturing facilities that are used by the brand name manufacturer. The labeling or packaging is, however, changed to remove the brand name or other trade dress. In some cases, a company may choose to sell an authorized generic at a lower cost than the brand-name drug product.

"Fifteen million Americans have food allergies—and the prevalence among children has increased by over 50% from 1997 to 2011—so it is critically important that this lifesaving medication is easily accessible and affordable for anyone at risk for anaphylaxis," said Gable, in her prepared statement. "We look forward to learning more about the pricing structure and availability for this new product, and will be posting more information at www.foodallergy.org as it becomes available.”

Epinephrine auto-injector products are known as “combination products” because they consist of a drug (epinephrine) and a device (the auto-injector). The development of generic combination products can be more challenging than typical drug products, and the FDA regularly takes steps to help guide industry through the process.

"The path to developing generic drug-device combination products like this one is challenging," added Dr. Gottlieb. "We remain committed to doing our part to provide scientific and regulatory clarity for sponsors seeking to develop complex generics, as well as prioritize the approval of medicines with little or no generic competition as part of our overarching effort to remove barriers to generic development and market entry of critically important medicines.”

Reference

FDA approves first generic version of EpiPen [news release]. Silver Spring, MD; August 16, 2018: FDA website. http://www.pharmacytimes.com/link/205. Accessed August 16, 2018.