USFDA approves Alembic Pharma Icatibant Injection for acute attacks of hereditary angioedema

Vadodara: Alembic Pharmaceuticals Limited today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Firazyr Injection, 30 mg/3 mL (10 mg/mL), of Takeda Pharmaceuticals U.S.A., Inc.

Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. 

Hereditary angioedema is a rare genetic disorder characterized by recurrent episodes of swelling (edema) in various parts of the body, including the face, limbs, abdomen, and throat. These episodes are caused by a deficiency or dysfunction of C1 esterase inhibitor, a protein involved in regulating the immune response and inflammation. HAE attacks can be triggered by stress, trauma, or certain medications, and they typically last for several days

This is the first peptide product approval from the USFDA received by the Company. Icatibant Injection has an estimated market size of US$ 112 million for twelve months ending Mar 2024 according to IQVIA. Alembic has a cumulative total of 205 ANDA approvals (177 final approvals and 28 tentative approvals) from USFDA.

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Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

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