TB CAB releases document outlining key considerations regarding pretomanid in anticipation of FDA public advisory committee meeting on the TB Alliance’s new drug application for pretomanid.
In March 2019, the U.S. Food and Drug Administration (FDA) accepted a new drug application for pretomanid, a drug candidate developed by the TB Alliance. The FDA will hold a public advisory committee meeting on the TB Alliance’s application on 6 June 2019. Members of the public can submit written comments in advance of the hearing and apply to deliver oral testimony at the hearing itself. As stakeholders in the TB community prepare for this historic hearing, the Global TB Community Advisory Board (TB CAB) shared its views on regulatory, research, and access considerations related to pretomanid.
The TB CAB stated its intentions for the considerations outlined in the document. The TB CAB hopes to stimulate dialogue among TB research stakeholders, inform the discussions and decisions of the FDA Antimicrobial Drugs Advisory Committee, FDA review staff, and other regulatory authorities, including the European Medicines Agency (EMA), and to share its expectations for how further investigations of, and access to, pretomanid should be managed by the TB Alliance and its recently announced commercial partner, Mylan.
To access the full document, click here.