Monday, July 15, 2024

Acute Myeloid Leukemia Treatment Advances as Alembic Pharmaceuticals Gains Tentative FDA Approval

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Alembic Pharmaceuticals has achieved a landmark moment with the tentative approval of Ivosidenib Tablets for acute myeloid leukemia (AML) by the U.S. Food and Drug Administration (FDA). This approval confirms the therapeutic equivalence of Alembic’s product to the reference Tibsovo Tablets, 250mg from Servier Pharmaceuticals, marking a significant advancement in the company’s portfolio.

Ivosidenib serves as a targeted treatment for patients harboring a specific IDH1 mutation, a condition that can be identified through an FDA-approved test. The medication is particularly beneficial for various patient demographics, such as those diagnosed with newly onset acute myeloid leukemia who are either above 75 years old or have comorbidities that disqualify them from intensive chemotherapy.

Alembic Expands Portfolio with FDA Nod for Acute Myeloid Leukemia Treatments

The therapy is prescribed for adults facing relapsed or refractory acute myeloid leukemia and individuals with advanced or metastatic Cholangiocarcinoma who have previously undergone treatment. The estimated market size for Ivosidenib Tablets stands at $114 million for the 12 months ending March 2024, according to IQVIA data.

This recent nod enhances Alembic’s extensive portfolio, now featuring 207 Abbreviated New Drug Application (ANDA) approvals from the USFDA, which includes 179 final and 28 tentative approvals. Notably, Alembic also received tentative approval for Bosutinib Tablets in 100mg and 500mg dosages, another targeted therapy for Philadelphia chromosome-positive chronic myelogenous leukemia, with a market size of $275 million for the same period.

Founded in 1907 and headquartered in India, Alembic Pharmaceuticals has established itself as a cornerstone in the global pharmaceutical industry, known for its vertically integrated research and development capabilities.

Acute Myeloid Leukemia

Alembic Pharmaceuticals Strengthens Market Position with New FDA Approvals and Targeted Therapies

The therapeutic equivalence of Ivosidenib Tablets to Tibsovo Tablets strengthens Alembic’s competitive edge. The estimated market size for Ivosidenib Tablets is $114 million. Alembic’s expanding portfolio now includes 207 ANDA approvals. Tentative approval of Bosutinib Tablets highlights Alembic’s focus on targeted leukemia treatments. Alembic’s long-standing presence in the industry underscores its reliability and innovation.

Alembic Pharmaceuticals continues its trajectory of growth and innovation with this latest approval, reinforcing its commitment to delivering advanced therapeutic solutions. The company’s strategy of focusing on targeted therapies not only enhances its market presence but also addresses the critical medical needs of specific patient populations. With a robust portfolio of ANDA approvals and a keen eye on market opportunities, Alembic is poised to make significant strides in the pharmaceutical landscape. Stakeholders can expect continued advancements and valuable contributions from Alembic in the field of targeted therapies, promising better outcomes for patients with complex health conditions.


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Resource: Alembic Pharmaceuticals, July 04, 2024

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