Demonstrate safety and adequacy of dose: CDSCO Panel Tells Intas Pharmaceuticals on Bevacizumab injection

New Delhi: Reviewing the justification presented by the drug major Intas Pharmaceuticals for not conducting the initial phase of clinical studies of the ophthalmic drug Bevacizumab injection, 25 mg/mL, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to demonstrate the safety and adequacy of the dose through initial phase clinical studies before carrying out Phase III clinical trials for the proposed drug.

This came after Intas Pharmaceuticals presented the justification for not conducting the initial phase of clinical studies before carrying out a Phase III clinical trial as the drug is approved by the European Medicines Agency (EMA) for the proposed indication.

Bevacizumab is a full-length, humanized monoclonal antibody directed against all the biologically active isoforms of vascular endothelial growth factor (VEGF-A). The antibody was initially designed and studied as an anti-angiogenic strategy to treat a variety of solid tumors. After approval by the US Food and Drug Administration, bevacizumab gained access to ophthalmology to treat various types of neovascular diseases.

Bevacizumab belongs to a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumours. This may slow the growth and spread of tumours. Bevacizumab acts by selectively binding circulating VEGF, thereby inhibiting the binding of VEGF to its cell surface receptors. This inhibition leads to a reduction in the microvascular growth of tumor blood vessels and thus limits the blood supply to tumors tissues.

At the recent SEC meeting for ophthalmology held on May 20, 2024, the expert panel reviewed the justification presented by Intas Pharmaceuticals for not conducting the initial phase of clinical studies before carrying out a Phase III clinical trial as the drug is approved by EMA for the proposed indication.

After detailed deliberation, the committee reiterated its earlier recommendation and stated:

“The firm should demonstrate the safety and adequacy of the dose through initial phase clinical studies before carrying out Phase III clinical trial.”

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