FDA Addresses Efficacy Concerns of New Hepatitis C Drug Approvals

Agency notes that expedited approvals do not compromise quality standards.

As the flood of new hepatitis C drugs have offered millions of patients hope for curing the disease, concerns have been raised regarding the approval process for some of these drugs by the FDA.

Highly effective new treatments for chronic hepatitis C, such as Viekira Pak, Sovaldi, and Harvoni, offer shorter treatment durations, significantly improved efficacy, and dramatically fewer side effects.

There is, however, persistent concerns from various groups regarding evidence used to justify the approval of some other newer drugs, which casts doubt on the effectiveness of these drugs, or is used by payers to deny treatment and reimbursement, the FDA noted.

As a result, the FDA Division of Antiviral Products in the Center for Drug Evaluation and Research (CDER) recently released a paper focusing on the scientific approaches and regulatory processes that bolster the development and approval of new drugs for the treatment of 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," lead author Poonam Mishra, MD, deputy director for CDER Safety, Division of Antiviral Products/Office of Antimicrobial Products in a press release. "Expedited approaches can be used without compromising efficacy standards for drugs that demonstrate breakthrough therapy potential."