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FDA Approves EpiPen Rival
The FDA has approved Symjepi (epinephrine injection, USP, 1:1,000 [0.3 mg], Adamis Pharmaceuticals) for the emergency treatment of allergic reactions (type I), including anaphylaxis.
Symjepi provides two prefilled, single-dose syringes of epinephrine (adrenaline), which is considered the drug of choice for immediate administration in acute anaphylactic reactions to insect stings or bites; in allergic reaction to foods (such as nuts), drugs, and other allergens; and in idiopathic or exercise-induced anaphylaxis.
Adamis Pharmaceuticals said it intends Symjepi to be a lower-cost rival to Mylan’s controversial EpiPen. The company is looking for a marketing partner and plans to set a price for the product before its launch in the second half of this year, according to Reuters.
Mylan faced severe criticism and congressional and legal investigations after it doubled the cost for a pair of EpiPens to approximately $600, angering consumers and putting it at the center of the ongoing debate over the high cost of prescription medications in the United States. The company has since offered its own generic version for approximately $300.
Symjepi joins other rival products on the market. Impax Laboratories’ Adrenaclick device is being sold through CVS Health’s drugstore chain for approximately $110 a pair.
Earlier this year, Kaleo began selling its Auvi-Q epinephrine autoinjector that it reacquired from Sanofi, but with little success so far. The company said it would make the product available at no cost to many consumers but would charge insurers $4,500.
Adamis Pharmaceuticals estimates that sales of prescription epinephrine products in 2016 totalled at least $1 billion, based on industry data.
Industry sources have estimated that up to 8% of U.S. children under the age of 18 years have a food allergy, and approximately 38% of those with a food allergy have a history of severe reactions. Anaphylaxis requires immediate medical treatment, including an injection of epinephrine. The number of prescriptions for epinephrine products has grown annually, as the risk of anaphylaxis and allergic reactions has become more widely understood.