Last Updated on October 2, 2024 by The Health Master
Cancer
This is a significant development for prostate cancer patients in India.
BDR Pharmaceuticals has secured approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) to manufacture and market Abiraterone Acetate Oral Suspension 1000 mg/5 ml.
This medication holds promise for those battling metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer.
SEC Grants Conditional Approval After Phase III Waiver Justification
The approval comes with a twist: a phase III clinical trial waiver.
BDR Pharmaceuticals successfully convinced the committee to forgo this typically mandatory testing phase.
However, a phase IV clinical trial involving 400-500 participants is mandated as a condition.
During the SEC’s oncology meeting on May 15, 2024, BDR Pharmaceuticals presented their case for the phase III waiver.
The key arguments likely revolved around:
- Similar Route of Administration and Dosing Regimen: The proposed Abiraterone Acetate Oral Suspension maintains the same delivery method and dosage as existing treatments, potentially reducing safety concerns.
- Established Efficacy in Other Regions: The company might have presented data on the drug’s effectiveness in regions like the European Union, where Abiraterone Acetate 1000 mg tablets were approved by 2021.
What is Abiraterone Acetate and How Does it Work?
Abiraterone Acetate is an antiandrogen medication, a class of drugs that disrupts the production of androgens (male sex hormones) in the body.
Androgens play a crucial role in the growth of certain prostate cancers.
By reducing androgen levels, Abiraterone Acetate helps control the progression of these cancers.
Here’s a closer look at Abiraterone Acetate’s mechanism of action:
- Targets Key Enzyme: The drug acts as a potent and selective inhibitor of an enzyme called 17 αhydroxylase/C17,20-lyase (CYP17). This enzyme is present in testicular, adrenal, and prostatic tumor tissues and plays a vital role in androgen biosynthesis.
- Irreversible Inhibition: Abiraterone Acetate irreversibly binds to CYP17, effectively stopping its function and hindering androgen production.
The Road Ahead: Phase IV Trial and Potential Benefits
While the SEC’s decision allows BDR Pharmaceuticals to manufacture and market Abiraterone Acetate Oral Suspension, the phase IV clinical trial remains crucial.
This trial will involve a larger patient group and provide further data on the drug’s safety and efficacy in the Indian population.
Potential Benefits of Abiraterone Acetate Oral Suspension:
- Improved Patient Compliance: Oral suspension can be easier to administer for some patients compared to tablets.
- Increased Treatment Options: The availability of a new formulation broadens treatment choices for prostate cancer patients in India.
- Potential Cost-Effectiveness: BDR Pharmaceuticals manufacturing the drug domestically could lead to lower costs compared to imported options.
However, it’s important to remember that the drug is still under evaluation in the Indian context.
Consulting a qualified oncologist is essential to determine if Abiraterone Acetate Oral Suspension is the right treatment option for you.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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