Enrique Conterno, FibroGen
FDA adcomm to review FibroGen’s chronic kidney disease drug in July
The FDA said Thursday that its Cardiovascular and Renal Drugs Advisory Committee of outside experts will convene on July 15 to review the safety and efficacy of FibroGen’s potential treatment for anemia in chronic kidney disease.
The drug, known as roxadustat, has been hit with cardiovascular safety questions recently as the company had to double back and inform the FDA of some post-hoc changes. The announcement that an advisory committee would be necessary, which came in early March, also was a surprise.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.
