Comment on Guidance for industry on pulmonary tuberculosis: Developing drugs for treatment.
The Global TB Community Advisory Board (TB CAB) and the Treatment Action Group (TAG) submitted a public comment on the U.S. Food and Drug Administration (FDA) draft guidance for industry entitled “Pulmonary Tuberculosis: Developing Drugs for Treatment.” The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the development of a single investigational drug as well as development of two or more unmarketed investigational drugs for use in combination.
Tuberculosis remains endemic in the United States and is epidemic in many parts of the world. Current treatment for tuberculosis involves administration of multiple-drug regimens for a minimum of 6 months. The development of new drugs for treatment of pulmonary tuberculosis remains an important public health goal. Some of the public health challenges to be addressed in the treatment of tuberculosis include: (1) The administration of new drug regimens for shorter periods of time; (2) new drugs that do not have drug-drug interactions with the drugs used to treat human immunodeficiency virus/acquired immunodeficiency syndrome; and (3) new drugs that are active in the treatment of patients with drug-resistant tuberculosis. This draft guidance addresses these issues in the context of clinical trial designs for new drugs. The draft guidance addresses the complexities of the superiority clinical trial design, where an investigational drug is found to be superior on a clinical endpoint while ensuring that all patients in trials receive appropriately active treatment regimens. The draft guidance includes a discussion of noninferiority clinical trial designs, with justification for a noninferiority margin in the setting of treatment-shortening regimens. The draft guidance also discusses clinical trials designed to include patients with drug-resistant tuberculosis.
The draft guidance, when finalized, will represent the Agency's current thinking on “Pulmonary Tuberculosis: Developing Drugs for Treatment.”