Ipsen's Six-Month Formulation of Triptorelin Pamoate Approved in China for Central Precocious Puberty
Ipsen
Biopharmaceutical Manufacturer
▎WuXi AppTec Content Team Report
Today (July 15), Ipsen（Ipsen）AnnouncementTriptorelin Pamoate for Injection (Six-Month Formulation)Approved by the National Medical Products Administration (NMPA) of China forCentral Precocious Puberty (CPP)Treatment.According to the information in the Ipsen press release, compared with short-acting preparations, long-acting sustained-release preparations can achieve continuous drug release for several months.Patients and their families only need to come to the hospital every six months for injection treatment and follow-up observation., thereby effectively reducing the number of injections and outpatient visits, and minimizing the adverse impact of long-term treatment on the daily lives of pediatric patients and their families.
In recent years, precocious puberty has become the second most common pediatric endocrine disorder after obesity. Central precocious puberty is one of the more prevalent forms of precocious puberty, caused by the premature activation of the hypothalamic-pituitary-gonadal axis and an increase in gonadotropin-releasing hormone (GnRH), leading to sexual development before the age of 7.5 in girls and 9 in boys. Long-acting gonadotropin-releasing hormone analogs (GnRHa) are the standard treatment recommended by international clinical guidelines for central precocious puberty. Triptorelin pamoate for injection is one such drug.The commonly used GnRHa drugs have a clinical application history of 38 years globally.
In China,Injectable Triptorelin PamoateJune FormulationPreviously approved in June 2023 in China for the treatment of prostate cancer, the product'sThree-Month FormulationHas also been approved in China for the treatment of central precocious puberty.According to the introduction in Ipsen's press release,Clinical studies have shown that the efficacy of the six-month formulation of triptorelin pamoate is not significantly different from that of the three-month formulation. The six-month formulation is a microsphere formulation with long-acting sustained-release properties, capable of releasing the drug at a certain rate to maintain effective blood drug concentration, reducing the frequency of administration and effectively decreasing the number of hospital visits for patients and their families.
Results from an international multicenter Phase 3 study indicate that,Triptorelin Pamoate for InjectionJune FormulationEnabling 93.2% of pediatric patients to reach pre-pubertal LH levels at 6 months(LH stimulation value ≤5IU/L), at 12 months97.7%, thereby delaying the progression of clinical signs of puberty in pediatric patients.
[1] Ipsen's Diphereline® Six-Month Formulation Approved, Becoming the First Ultra-Long-Acting Formulation in the Field of Central Precocious Puberty Treatment in China.Retrieved July 15，2024. From https://mp.weixin.qq.com/s/v4lmOgKHhJDCPwk0pdQjgw
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