An abbreviated new drug application was approved by the FDA for leuprolide acetate injection as treatment of patients with advanced prostate cancer.
The FDA has granted approval to an abbreviated new drug application for leuprolide acetate injection for patients with advanced prostate cancer, according to a press release from Amneal Pharmaceuticals.1
This leuprolide acetate injection is indicated for palliative treatment in patients with advanced prostate cancer. The abbreviated application is used for the review and approval of generic drugs.2
“We are making tremendous progress expanding our injectables business. This latest new product is another key therapeutic for the institutional market and another complex, high-value launch by the team,” Harsher Singh, senior vice president for Amneal Biosciences, said in the press release.
Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone which acts as an inhibitor of gonadotrop in secretion. Then injection is a sterile, aqueous, clear, solution intended for subcutaneous injection.
The injection is available in a 2.8 mL multiple-dose vial containing leuprolide acetate, 5 mg/mL, sodium chloride, USP (6.3 mg/mL) for tonicity adjustment, benzyl alcohol, NF as a preservative (9 mg/mL), and water for injection, USP.
In preclinical studies following an initial stimulation, administering leuprolide acetate continuously resulted in suppression of ovarian and testicular steroidogenesis that was reversible upon the discontinuation of the drug. Leuprolide acetate also has shown to inhibit the growth of select hormone-dependent tumors, including prostatic tumors in Noble and Dunning male subjects, DMBA-induced mammary tumors in female subjects, and atrophy of the reproductive organs.
Data from humans showed that when leuprolide acetate was subcutaneously administered in single daily doses, it led to an initial increase in circulating levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This resulted in a transient increase in gonadal steroids levels while continuous and daily administration of the drug led to decreased levels of LH and FSH in patients.
In male patients, testosterone was reduced to castrate levels. For female patients who were premenopausal, estrogens were reduced to post-menopausal levels. These decreases were occurred within 2 to 4 weeks following the initiation of treatment. Castrate levels of testosterone have been shown for periods of up to 5 years in patients with prostate cancer.
Then in a controlled study, the use of subcutaneous leuprolide acetate administered at 1 mg daily was compared with diethylstilbestrol given at 3 mg daily. After 2 years, survival rates for the 2 groups and objective response to treatment were similar between.