Committee for Medicinal Products for Human Use

Asthma inhaler
#Asthma #AstraZeneca #Committee for Medicinal Products for Human Use #European Medicines Agency

Asthma drug Trixeo recommended for approval in the EU

AstraZeneca’s fixed-dose triple-combination Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) has been recommended for approval in the EU for the maintenance treatment of asthma in patients 12 years of age and older.  It is recommended in patients who are not adequately controlled by a combination of a medium… Read More

#News #Regulatory

The European Medicines Agency building
#Accelerated assessment #Committee for Medicinal Products for Human Use #European Medicines Agency #Rare disease

EMA accelerates assessment of drug for rare disease APDS

A potential new treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) has been validated for scientific evaluation under an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP).  Pharming’s investigational drug leniolisib, a selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, will be evaluated as a… Read More

#News #Regulatory