CDSCO Panel agrees with Bharath Serum's clarification on adverse event of Leuprolide Acetate for Injection

Despite the variety of conditions indicated for treatment with leuprolide, the mechanism of action underlying efficacy is the same in all cases. As a GnRHR agonist, leuprolide binds to and initially activates downstream LH and FSH release; this initial spike in gonadotropin levels is responsible for some of the adverse effects associated with treatment. After 2-4 weeks of treatment, continuous stimulation of GnRHR results in feedback inhibition and significant downregulation of LH, FSH, and their corresponding downstream effects, producing a therapeutic benefit. These effects are reversible upon treatment discontinuation.

Bharath Serum presented the Phase III clinical trial report of Leuprolide Acetate for Injection 3.75 mg (Depot) at the previous SEC meeting on 24.8.23.

The committee took note of the findings in detail, highlighting that hot flashes, one of the drug's most common side effects, were found to occur very infrequently in clinical trials compared to the reported percentage.

The committee therefore recommended that the firm should submit clarification to CDSCO for further consideration.

In continuation, at the recent SEC meeting for Oncology and Hematology held on 7th and 8th December 2023, Bharath Serum presented the clarification with respect to the adverse event of hot flashes during the Phase III CT report of Leuprolide Acetate for Injection 3.75 mg (Depot).

After detailed deliberation, the committee noted and agreed to the results of the presented phase III CT study report.

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