Ngenla (somatrogon) withdrawal of application for variation to marketing authorisation for growth hormone deficiency. - Pfizer

The EMA revealed that Pfizer had withdrawn its  application submitted on December 20, 2024, for variation to the marketing authorisation for Ngenla to treat adults with growth hormone deficiency.  The decision comes after the EMA indicated that the drug did not demonstrate sufficient efficacy in clinical trials for the adult demographic. The withdrawal of the application,  follows a pivotal study involving 202 adults with growth hormone deficiency. Participants received either Ngenla or a placebo over a 26-week period. The primary measure of success was the reduction in trunk fat mass, assessed using dual-energy X-ray absorptiometry (DXA). The results failed to show a significant difference between the Ngenla and placebo groups, leading to doubts about the drug’s effectiveness in adults. Pfizer stated that the decision to withdraw the application allows for additional analyses to better understand Ngenla’s potential benefits in the target population