MORRISTOWN, N.J., Jan. 29, 2020 /PRNewswire/ -- Pharmacosmos Therapeutics Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Monoferric® (ferric derisomaltose) injection 100 mg/mL. Monoferric® is an intravenous iron indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis dependent chronic kidney disease.
"We are very pleased with the FDA's approval of Monoferric® as the first intravenous iron product approved in the United States for the infusion of 1000 mg as a single dose in one visit for patients with iron deficiency anemia," said Michael Ryde, CEO of Pharmacosmos Therapeutics Inc. "We are excited to provide this new innovative treatment to US physicians."
"Iron deficiency anemia remains a serious health issue both in the United States and globally," said Michael Auerbach, MD, FACP, Clinical Professor of Medicine at Georgetown University School of Medicine in Washington DC. "I am very happy that Monoferric®, which is supported by a robust clinical trial programme, is now approved in the United States for administration of a total dose infusion in a single visit, making it the first intravenous iron formulation in the United States to receive such an approval."
The safety and efficacy of Monoferric® for treatment of IDA were evaluated in two randomized, open-label clinical trials with active control (FERWON studies) performed in a total of 3050 patients with IDA of different etiologies. Trial 1 (FERWON-IDA) included patients with IDA who had intolerance to oral iron or who had had unsatisfactory response to oral iron or for whom there was a clinical need for rapid repletion of iron stores. Trial 2 (FERWON-NEPHRO) included patients with IDA who had non-dialysis dependent chronic kidney disease. In these two 8-week trials, patients were randomized 2:1 to treatment with Monoferric or iron sucrose. Monoferric was intravenously administered as a single dose of 1000 mg.
In Trial 1, 1512 adult patients with IDA caused by different etiologies were randomized in a 2:1 ratio to treatment with Monoferric® or iron sucrose. The efficacy of Monoferric® was established based upon the change in Hb from baseline to week 8. Non-inferiority was demonstrated for change in Hb from baseline to Week 8. Patients in both arms of this study experienced a mean change in hemoglobin of 2.49 g/dL from baseline to week 8. These increases were statistically significant.
Trial 2 enrolled 1538 patients with NDD-CKD. The efficacy of Monoferric® was established based upon the demonstration of non-inferiority for change in hemoglobin from baseline to Week 8. Patients receiving Monoferric® experienced a mean increase in hemoglobin from baseline to Week 8 of 1.22 g/dL, and patients treated with iron sucrose experienced a mean increase in hemoglobin from baseline to Week 8 of 1.14 g/dL. Based upon these results, non-inferiority was confirmed.
In Trial 1 and Trial 2 combined, adverse reactions were reported in 8.6% of patients treated with Monoferric®. The most common adverse reactions reported were nausea (1.2%) and rash (1.0%). Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric® group.
In the full, global development program, Monoferric® has been evaluated in twenty-five clinical trials enrolling more than 5,800 patients.
Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 daltons and a narrow molecular weight distribution that is almost devoid of mono- and disaccharides.
Ferric derisomaltose is also known as iron isomaltoside 1000. Iron isomaltoside 1000 is the generic name initially approved in the EU and in some other markets, whereas ferric derisomaltose is the international nonproprietary name (INN) and United States Adopted Name (USAN).
Monoferric® was first approved outside North America in EU in 2009 as Monofer® (iron isomaltoside 1000 injection) and is currently marketed in more than 30 countries worldwide, including in the EU, Canada, and Australia.
About Pharmacosmos Therapeutics Inc.
Pharmacosmos Therapeutics Inc. has been established to commercialize Monoferric® in the rapidly growing U.S. intravenous iron market. Structured to be agile and fast-moving, Pharmacosmos Therapeutics will bring together the resources required to drive growth and an experienced, high-performing team with the shared purpose of bringing a new treatment option to patients in need of intravenous iron.
Pharmacosmos Therapeutics Inc. is based in Morristown, New Jersey.
About Pharmacosmos Group
Pharmacosmos Group, headquartered in Holbaek, Denmark, and founded in 1965, is a highly specialised company focused on carbohydrate chemistry and a global leader in the development of innovative treatments for patients suffering from iron deficiency and iron deficiency anemia. With companies in the UK, Nordics, Germany and recently also in the US, and through partners, Pharmacosmos markets its products across the world. With a strong and ongoing commitment to R&D, Pharmacosmos is able to leverage a unique carbohydrate production platform along with deep expertise in the synthesis of iron-carbohydrate complexes.
Important Safety Information
Monoferric® (ferric derisomaltose) injection 100 mg/mL is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, and in adult patients with non-dialysis dependent chronic kidney disease.
Monoferric® is contraindicated in patients with a history of serious hypersensitivity to Monoferric® or any of its components.
For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs. For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs. The dosage of Monoferric is expressed in mg of elemental iron. Each mL of Monoferric contains 100 mg of elemental iron.
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric®. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric® administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric® when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.
In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric® treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient. Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric®. Adverse reactions related to treatment and reported by ≥ 1% of the treated patients in the clinical trials include nausea and rash.
Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Monoferric® to patients with iron overload.
Please see full prescribing information at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208171s000lbl.pdf
To report SUSPECTED ADVERSE REACTIONS, contact Pharmacosmos at 1-888-828-0655 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Iron Deficiency Anemia
Iron deficiency anemia (IDA) is a debilitating condition that affects almost 1 billion people worldwide. IDA is often associated with many chronic disorders such as renal diseases (including chronic kidney disease), cancers (including chemotherapy-induced anemia), gynecological disorders (including abnormal uterine bleeding), and inflammatory bowel disease.
SOURCE Pharmacosmos Therapeutics Inc.