January 20, 2020

The U.S. FDA has approved Monoferric™ (ferric derisomaltose) injection, manufactured by Pfizer, to treat iron deficiency anemia in adult patients who have intolerance to oral iron or have had an unsatisfactory response to oral iron, as well as adult patients who have non-hemodialysis dependent chronic kidney disease.

Iron deficiency anemia is the most common form of anemia. It occurs when the body lacks enough iron to produce sufficient hemoglobin, a substance present in red blood cells that is responsible for carrying oxygen. Causes include blood loss, inadequate iron intake, and lack of ability to absorb iron. The signs and symptoms can be subtle, meaning patients may go undiagnosed for years. They include fatigue, pale skin, shortness of breath, dizziness, tingling or crawling sensations in the legs, cold hands and feet, brittle nails, headaches, a fast or irregular heartbeat, and cravings for non-food items such as ice, dirt, or clay.

In clinical studies, Monoferric demonstrated non-inferiority to iron sucrose injection, an FDA-approved product used to treat iron deficiency anemia. For patients who weigh at least 50kg (110 pounds), the recommended dose is 1,000mg administered via intravenous (IV) infusion over the course of 20 minutes. Recommended dosing for patients who weigh less than 50kg is 20mg/kg of body weight. Treatment with Monoferric should be repeated if iron deficiency anemia reoccurs. The product must be administered in a setting where personnel and therapies are immediately available to treat serious hypersensitivity reactions. Dosage is expressed in milligrams of elemental iron.

Monoferric will be available in single-dose vials containing 1,000mg iron/10mL, 500mg iron/5mL, or 100mg iron/mL. Launch and pricing plans have not been announced.

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