CDSCO Panel agrees with Bharath Serum's clarification on adverse event of Leuprolide Acetate for Injection
New Delhi: In line with the clarification presented by the pharma major Bharath Serum with respect to the adverse event of hot flashes during the Phase III clinical trial (CT) report of Leuprolide Acetate for Injection 3.75 mg (Depot), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has agreed that the adverse event of hot flashes...
New Delhi: In line with the clarification presented by the pharma major Bharath Serum with respect to the adverse event of hot flashes during the Phase III clinical trial (CT) report of Leuprolide Acetate for Injection 3.75 mg (Depot), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has agreed that the adverse event of hot flashes which is one of the most common side effects with the drug was found to be very low in clinical trials as compared to the reported percentage.
This came after Bharath Serum presented the clarification concerning the adverse event of hot flashes during the Phase III CT report of Leuprolide Acetate for Injection 3.75 mg (Depot).
Leuprolide is a peptide-based Gonadotropin-releasing hormone (GnRH) receptor superagonist used for the palliative treatment of prostate cancer, uterine leiomyomata, endometriosis, and central precocious puberty.
Gonadotropin-releasing hormone (GnRH) is a naturally occurring decapeptide that modulates the hypothalamic-pituitary-gonadal (HPG) axis. GnRH binds to corresponding receptors (GnRHRs) on the anterior pituitary gonadotropes, which in turn release luteinizing hormone (LH) and follicle-stimulating hormone (FSH); these, in turn, affect the downstream synthesis and release of the sex hormones testosterone, dihydrotestosterone, estrone, and estradiol.
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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