ViroPharma has begun the roll-out in Europe of Plenadren, which it says is "the first true innovation in over 50 years in the treatment of adrenal insufficiency".
The firm has launched Plenadren (hydrocortisone modified-release tablets) in Denmark, after it was approved by the European Commission in November 2011. The once-daily pill is designed to better mimic the body’s normal, cortisol profile, compared with standard glucocorticoid treatment.
Plenadren proved to be effective and well-tolerated in a Phase II/III trial compared to standard therapy, also avoiding the unphysiological cortisol peaks seen with the latter. ViroPharma noted that these peaks are thought to be associated with an increased risk of morbidity and premature mortality.
Anna Nilsson of the Sahlgrenska University Hospital in Gothenburg, Sweden and principal investigator for all Plenadren studies, said "there is a clear need in the treatment of AI for an oral hydrocortisone replacement therapy that better resembles the body’s natural cortisol production, that can be given once a day and that may improve patients’ metabolic status and compliance to treatment". She added that “a new therapeutic option for the first time in 50 years, that appears to achieve this is exciting news".
AI is a rare, chronic and potentially fatal endocrine disorder that affects less than 4.5 in 10,000 people in Europe.