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Amneal Pharmaceutical receives USFDA approval for RELEUKO™ (filgrastim-ayow), a biosimilar referencing Neupogen on March01, 2022. RELEUKO™ was developed in collaboration with Kashiv Biosciences. It is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy. Amneal expects to launch RELEUKO™ in the third quarter of 2022, along with a full patient support program.
The Company is planning for a pegfilgrastim biosimilar referencing Neulasta® and a bevacizumab biosimilar referencing Avastin® to launch in 2022. Both are being reviewed by the FDA.
RELEUKO™ in the U.S. is indicated:
- To decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever.
- To reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
- To reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
- To reduce the incidence and duration of sequelae of severe neutropenia‚ (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.
IMPORTANT SAFETY INFORMATION
- Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.
- Before taking RELEUKO™, consult to your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.
WARNINGS AND PRECAUTIONS
- Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
- Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue RELEUKO™in patients with ARDS.
- Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving RELEUKO™. Discontinue RELEUKO™if sickle cell crisis occurs.
- Serious allergic reactions, including anaphylaxis: Permanently discontinue RELEUKO™ in patients with serious allergic reactions.
- Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on RELEUKO™. Consider dose-reduction or interruption of RELEUKO™in patients with kidney injury.
- Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using RELEUKO™in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
- Decreased platelet count (thrombocytopenia); increased white blood cell count (leukocytosis) and inflammation of your blood vessels (cutaneous vasculitis) have been reported. Monitor platelet counts and white blood cell count.
ADVERSE REACTIONS
Most common adverse reactions in patients:
- With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs are pyrexia, pain, rash, cough, and dyspnea.
- With AML are pain, epistaxis and rash.
- With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by Bone Marrow Transplant is rash.
- With severe chronic neutropenia are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia
