J&J Seeks Label Expansion for Spravato Nasal Spray in EU
Johnson & Johnson’s JNJ submitted a type II variation application to the European Medicines Agency (EMA), seeking label expansion of Spravato (esketamine) nasal spray in patients with major depressive disorder (MDD) who have current suicidal ideation with intent in Europe.
A supplemental new drug application seeking a similar label expansion was filed in the United States in October this year. The application was based on data from two phase III studies, ASPIRE I & II, which demonstrated that Spravato combined with comprehensive standard of care led to rapid reduction of depressive symptoms in adult MDD patients who have active suicidal ideation with intent.
J&J’s shares have performed in line with the large-cap pharma industry in the past year. The stock has returned 14.9% ...