FDA Addresses Concerns on Approval of Drugs to Treat Chronic Hepatitis C

Article

Treatment options for chronic hepatitis C, a serious and life-threatening infection, have improved substantially and several new regimens with shorter durations and improved efficacy and safety profiles are now available. Groups have raised concerns about the evidence used to support the approval of some newer drugs, however, and the issue has been used to cast doubt on their efficacy and even to question treatment or deny reimbursement.

To address these concerns, the Food and Drug Administration (FDA)'s Division of Antiviral Products in the Center for Drug Evaluation and Research (CDER) has published a paper that highlights the agency's scientific approaches and regulatory processes that support the development and approval of promising drugs to treat hepatitis C.

"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," says Dr. Poonam Mishra, deputy director for Safety, Division of Antiviral Products/Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research and lead author of the Hepatology paper. "Expedited approaches can be used without compromising efficacy standards for drugs that demonstrate breakthrough therapy potential."

Source: Wiley

Recent Videos
Pathogen Playbook Presenter: Sharon Ward-Fore, BS, MS, MT(ASCP), CIC, FAPIC
Mark Wiencek, PhD
Rebecca Crapanzano-Sigafoos, DrPH, CIC, AL-CIP, FAPIC
The CDC’s updated hospital respiratory reporting requirement has added new layers of responsibility for infection preventionists. Karen Jones, MPH, RN, CIC, FAPIC, clinical program manager at Wolters Kluwer, breaks down what it means and how IPs can adapt.
Studying for the CIC using a digital tablet and computer (Adobe Stock 335828989 by NIKCOA)
Infection Control Today's Conversations with the HSPA President, Arlene Bush, CRCST, CER, CIS, SME, DSMD, CRMST
Infection Control Today's Conversations with the HSPA President, Arlene Bush, CRCST, CER, CIS, SME, DSMD, CRMST
Cheron Rojo, BS, FCS, CHL,  CER, CFER, CRCST
Matthias Tschoerner, Dr Sc
Standardizing Cleaning and Disinfection
Related Content