Ipsen S.A. (EPA: IPN; OTCMKTS: IPSEY) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its six-month dosage form of Diphereline (triptorelin), a treatment for central precocious puberty (CPP), a condition that leads to early sexual development in children. This makes Diphereline the first and only ultra-long-acting dosage formulation available for CPP in China, offering a significant advancement in treatment options for this patient population .
Diphereline, a gonadotropin-releasing hormone (GnRH) agonist analog, has been a standard treatment for CPP worldwide for the past 38 years. Traditionally available in a three-month dosage, clinical studies have demonstrated that the six-month dosage is as effective as its shorter-term counterpart. The new formulation leverages a particulate form with long-lasting and sustained-release characteristics, which releases the drug at a steady rate to maintain effective blood-drug concentrations. This not only reduces the frequency of administration but also minimizes the number of medical visits required for children and their families, enhancing convenience and compliance .
The approval of the six-month Diphereline dosage in China comes as part of Ipsen’s commitment to improving pediatric healthcare and providing innovative solutions to address unmet medical needs. With this new dosage form, Ipsen is poised to make a significant impact on the treatment landscape for CPP in China, offering patients and healthcare providers a more convenient and potentially more effective treatment option .- Flcube.com
