Manufacturer announces production increase for central precocious puberty injection
The manufacturer of a leuprolide acetate suspension injection approved for children with central precocious puberty announced a production increase after reports of a U.S. shortage for a different leuprolide acetate injection product.
In a press release, Tolmar Pharmaceuticals affirmed the full availability of leuprolide acetate (Fensolvi) for injectable suspension in its 6-month dose (45 mg) for pediatric patients with central precocious puberty. The company also announced a production increase in response to reports of a shortage in the U.S. for a different leuprolide acetate injection product. On July 24 and Aug. 3, the FDA listed Lupron Depot-Ped (3 months, 30 mg) as not available and on backorder in its database of current and resolved drug shortages and discontinuations. The listing indicates the estimated duration of this shortage is currently unknown.
“Tolmar is pleased to step up production in our state-of-the-art [current good manufacturing practice] facilities to help ensure that children with central precocious puberty and their parents are able to access their treatment on schedule,” Anil D’Souza, CEO of Tolmar, said in the release. “Fensolvi is manufactured to the highest-quality standards in our northern Colorado plants, and we are able to fill any short- or long-term gaps in the supply of this drug for those who need it.”
Leuprolide acetate suspension injection is a gonadotropin-releasing hormone agonist in a polymeric gel form. After subcutaneous injection of 0.375 mL, the gel becomes a solid that remains under the skin and releases leuprolide over time. The small volume and extended release allow greater flexibility in choosing injection sites and fewer injections — every 6 months rather than monthly or every 3 months, according to the release.
“During the global COVID-19 pandemic, parents and patients should be able to remain focused on keeping childhood simple instead of worrying about a missed treatment or an extra office visit,” D’Souza said. “Tolmar has a full inventory of [active pharmaceutical ingredients] and the other components of Fensolvi, and the capacity to manufacture sufficient supply of the drug for the pediatric endocrinology community and patients at this time.”
As Healio previously reported, the FDA approved leuprolide to be dosed every 6 months for use in treating children aged at least 2 years with central precocious puberty, defined as sexual development in girls younger than 8 years and boys younger than 9 years.