The United States Food and Drug Administration’s (FDA) Division of Antiviral Products in the Center for Drug Evaluation and Research (CDER) recently released a paper that addresses the public concerns toward the FDA’s recent approval of treatments for chronic hepatitis C.
Chronic hepatitis C is a dangerous, life-threatening infection. Multiple new regimens have shown significant improvement with regards to safety and efficiency as well as the duration of the treatments.
The public and concerned groups have asked questions about the validity of the evidence that the FDA used to approve a few of the new treatments. This concern has caused doubt concerning the treatments’ efficiency, and there has even been a question of treatments and denied reimbursement.
"FDA's approach to evaluation of recent hepatitis C drugs underscores the agency's flexibility in considering innovative or alternative trial designs for drugs that have demonstrated highly promising outcomes in early phase development," Poonam Mishra, deputy director in the FDA's Center for Drug Evaluation and Research and lead author of the Hepatology paper, said. "Expedited approaches can be used without compromising efficacy standards for drugs that demonstrate breakthrough therapy potential."