USFDA Gives Nod to Icatibant Injection of Alembic Pharmaceuticals 

USFDA gives the nod to Icatibant Injection Drug of  Alembic Pharmaceuticals which will be used to treat the hereditary angioedema (HAE)

by Damodharan N

Updated Jun 18, 2024

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USFDA Gives Nod to Icatibant Injection of Alembic Pharmaceuticals

Alembic Pharmaceuticals Limited (Alembic) announced on June 17th that it has received final approval from the US Food and Drug Administration (USFDA) for its Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe.

Icatibant Injection is used for treating acute attacks of hereditary angioedema (HAE) in adults aged 18 and older. This approval marks Alembic's first peptide product to be approved by the USFDA. The approved drug is equivalent to Firazyr Injection by Takeda Pharmaceuticals U.S.A., Inc.

The estimated market size for Icatibant Injection is around USD 112 million for the year ending in March 2024, according to IQVIA. With this latest approval, Alembic now has a total of 205 Abbreviated New Drug Application (ANDA) approvals from the USFDA, including 177 final approvals and 28 tentative approvals.

Read the full statement here.

Hereditary Angioedema

Hereditary angioedema (HAE) is a genetic disorder where the body lacks or has a dysfunctional C1-inhibitor protein, causing sudden and severe swelling in areas like the upper airway, skin, and gastrointestinal tract. The most dangerous complication is upper airway swelling, which can lead to suffocation, though it is rare.

Managing HAE includes treating acute attacks with medications, which blocks swelling, and using long-term strategies to prevent attacks by avoiding triggers and possibly taking preventive medications.

Patients often learn to self-administer treatments, and coordinated care among healthcare providers is crucial for effective management. The current drug developed by Alembic Pharmaceuticals called icatibant single-Dose Prefilled Syringe is hopes to address the swelling issue which will hit the markets for sale. 

Know more about the Disease from National Library of Medicine portal by accessing the link NCBI Hereditary Angioedema Health Data

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Alembic Pharmaceuticals 

Alembic Pharmaceuticals Limited, founded in 1907 and headquartered in India, is a major pharmaceutical company that produces and markets India Formulations, International Generics, and Active Pharmaceutical Ingredients (APIs) globally. They are committed to advancing the generics pharmaceutical industry through technology and innovation.

Alembic is a publicly listed, vertically integrated research and development company with facilities approved by international regulatory authorities, including the USFDA. Known as a leader in branded generics in India, their products are well-recognized by doctors and patients, supported by a marketing team of over 5000 members.

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The FDA (Food and Drug Administration) has been dedicated to promoting and protecting public health for over 100 years. With more than 18,000 employees working across all 50 states and internationally, the FDA ensures the safety and effectiveness of human and veterinary medicines, biological products, and medical devices.

Additionally, the FDA regulates the safety of food and the nation’s food supply. It also regulates cosmetics, radiation-emitting devices, and tobacco products, playing a crucial role in safeguarding daily consumer products.

USFDA gives Nod to Icatibant Injection of  Alembic Pharmaceuticals - FAQs

1. What is Icatibant Injection?        

Icatibant Injection is a medication used to treat acute attacks of hereditary angioedema (HAE) in adults.

2. What is Hereditary Angioedema (HAE)?  

HAE is a genetic disorder that causes sudden and severe swelling in various body parts, potentially affecting breathing and digestion.

3. How does Icatibant Injection work?  

Icatibant blocks the activity of certain chemicals that cause swelling in HAE attacks, helping to reduce symptoms.

4. Who can use Icatibant Injection?  

It is approved for adults aged 18 and older who experience acute HAE attacks.

5. Who manufactures Icatibant Injection?  

Icatibant Injection is manufactured by Alembic Pharmaceuticals Limited, which received approval from the USFDA for this product.

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