Insmed's Amikacin Has US FDA Questioning Microbiological Endpoint Vs. Clinical Benefit

 
• By Sue Sutter

Whether converting positive sputum culture to negative will lead to an improvement in how a person feels, functions or survives is at the heart of agency’s review of Insmed’s amikacin liposome inhalation suspension for accelerated approval in mycobacterial lung disease.

Gold brass balance scale isolated on white background. Sign of justice, lawyer
US FDA is weighing whether microbiological clearance equals clinical benefit in patients with nontuberculous mycobacterial lung disease.

More from US FDA Performance Tracker

More from Regulatory Trackers