![]() While this is an interim snapshot of the enliGHten trial, additional data from over 60 participants who have completed lonapegsomatropin treatment are anticipated in a future final analysis. The adverse event profile remained consistent with what was observed in the heiGHt and fliGHt trials, with no new safety signals.Ĭonclusions: In this analysis, 36 children and adolescents who completed therapy with lonapegsomatropin in the enliGHten trial approached or exceeded average parental height SDS. Participants who completed the trial were Tanner stage 4 or 5. The majority of completers (61.1%) met or exceeded average parental height SDS. Novo Nordisk, Orchard, Pfizer, Sandoz, Sanofi Genzyme, Tolmar, and Vertice and. The mean (SD) height SDS at last visit was -0.38 (0.74), close to the average parental height SDS of -0.33 (0.83). Abbvie, Ascendis, BioMarin, Bluebird Bio, Endo Pharmaceuticals. The mean (SD) duration of treatment with lonapegsomatropin was 2.2 (0.66) years and total treatment duration with GH was 3.5 (0.88) years. All participants who completed the trial had been previously treated with daily GH prior to beginning lonapegsomatropin and the mean (SD) age at baseline was 14.5 (1.44) years (range 10.8- 17.4 years). Of these, 14 participants had reached bone age of >14 years (girls) or >16 years (boys). Results: At Week 130 (data snapshot date: September 01, 2021), 36 participants had completed the trial per investigator judgement that treatment for pGHD was no longer necessary. Participants were determined to have completed the trial either by achieving near adult height (bone age >14 years or >16 years ) or because treatment for pGHD was no longer necessary in these children based on investigator judgement. Endo Pharmaceuticals’ specialty portfolio includes products for urology, men’s health, orthopedics and endocrinology. Endo Pharmaceuticals Inc., headquartered in Malvern, PA, develops and markets high-value, quality branded pharmaceutical products for patients in need. Methods: Upon entry into enliGHten, all participants received lonapegsomatropin via vial/syringe, with subsequent switch to TransCon hGH Auto-Injector when available. Endo Pharmaceuticals 7,444 followers on LinkedIn. At enliGHten Week 130, the height standard deviation score (SDS) mean (standard deviation ) was -0.64 (0.85) compared with baseline value of -1.56 (0.88), with an annualized height velocity mean (SD) of 7.6 cm/year (1.85) (ENDO 2022, Thornton et al, presentation RF26|PMON332). The ongoing open-label extension trial, enliGHten, enrolled participants from the heiGHt or fliGHt trial (switch study) to assess the long-term safety and efficacy of lonapegsomatropin treatment. In the pivotal phase 3 heiGHt trial, lonapegsomatropin demonstrated noninferior and superior annualized heigh velocity (AHV) and a comparable safety profile to daily somatropin in children with GHD. Background: Lonapegsomatropin (TransCon hGH) is a once-weekly prodrug of somatropin, approved for the treatment of pediatric growth hormone deficiency (pGHD) by the US FDA and EMA.
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