The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients. This is a key milestone as it sets the stage for a cheaper competition that may lower prices. The new generic, which won’t carry the EpiPen name, will be made by Israeli generic manufacturer Teva Pharmaceuticals. It was approved after the FDA issued new guidance for generic copies of products like the EpiPen, which combines a drug with a specialized device to deliver it fast when people have life-threatening allergic reactions.
Teva Pharmaceuticals faced so many challenges in getting their product approved by the FDA, partly because it is a complex generic, meaning the product includes both an injector device and a drug. In 2015, Mylan actively fought the approval of the drug, sending a citizen petition to the FDA. In 2016, FDA rejected Teva’s initial application, citing “major flaws”. Under FDA Commissioner Scott Gottlieb, the agency is tasked with the responsibility of ensuring a smooth regulatory pathway for “complex generics” that are difficult to copy.
The approval is a victory for the FDA as the Trump administration seeks to deliver on its promise to lower drug prices. “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,” FDA Commissioner Dr. Scott Gottlieb said in a statement.
Teva did not issue any formal statement on how much it would charge for the generic product or when it would be available in the market. “We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market,” the company said in a statement. Teva’s generic brand will compete against Mylan’s own authorized generic, which already has steeply eroded its brand-name sales. Roughly $1 billion in sales of the brand-name version of brand name EpiPen in 2016 dropped by more than half in 2017.
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 using the brand name’s existing new drug application and uses the same formulation, process and manufacturing facilities used by the brand name manufacturer, according to the FDA. The label and packaging used by the brand name are also changed.
Anaphylaxis is a serious and life-threatening medical condition that requires immediate medical treatment, including a prompt injection of epinephrine and a trip to a hospital emergency room. If it isn’t treated properly, anaphylaxis can be fatal. Life-threatening allergies can include reactions to insect bites or stings, foods, medications, latex or other causes. Certain people are more at risk of anaphylaxis, especially people with asthma and a family history of allergies and anaphylaxis. Symptoms of anaphylaxis typically start within 5 to 30 minutes of coming into contact with the allergen to which you are allergic. In some cases, it may take more than an hour for you to notice anaphylactic symptoms. Warning symptoms of anaphylactic reaction include;
- Red rash, with hives that is usually itchy.
- Pronounced swelling in different areas of the body such as the eye, mouth or throat
- Difficulty swallowing food substances
- The feeling of impending doom
- Difficulty breathing with coughing
- Hoarse voice
- Neck and chest tightness
- Pale or red color to the face and body.
- Stomach upset, constipation or diarrhea.
Because of this risk, they must carry an emergency dose of epinephrine at all times. Many must keep more than one dose at hand.
Epinephrine exerts its effect by first constricting the blood vessels, which reduces swelling in the airway and increase blood flow in the veins. When administered intramuscularly or subcutaneously, it has a rapid onset and short duration of action. Epinephrine injection (auto-injector) is designed for this purpose, to achieve a fast result when administered to allergic patients.
Epinephrine injection also comes with its side effects. The most common side effects reported by users are restlessness, irregular heartbeat, cold hands and feet, weakness, anxiety, tremor, dizziness, excessive sweating, nausea and vomiting, headaches, chest tightness and or difficulty breathing. In rare and extreme cases, serious skin and soft tissue infections have been reported following the use of epinephrine injection. Use of epinephrine is highly contraindicated in patients with heart disease, as this may trigger angina pectoris (severe pain in the chest) or ventricular arrhythmias (abnormal heart rhythm). Extreme caution should be taken following the use of epinephrine injection. It should not be injected directly into the vein, buttock, a nerve, hands or feet. To prevent injection-site lesions or ulcers, the leg should be restricted from moving during injection.
The American Academy of Allergy, Asthma, and Immunology is “very pleased” with the approval of the new generic, said Dr. Robert Wood, president of the academy and director of pediatric allergy and immunology at Johns Hopkins Medicine in Baltimore. “Any measures that can improve the availability and costs of these medications is a real benefit for our patients,” Wood said. There have been recent concerns about shortages of EpiPens, which has been especially an issue as families are refilling prescriptions for back-to-school planning,” he said. “We strongly support any measures that can help provide these lifesaving medications in a more cost-effective manner, especially given the concerns about the shortages of EpiPens.”
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