LPAD pathway: FDA finalizes guidance
The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining its recently created program intended to spur the development of new antibiotic and antifungal drugs intended for limited patient populations.The final guidance comes more than two years after FDA issued the draft guidance for comment and a year after the agency held a public meeting to receive input on the guidance from the scientific community. (RELATED: FDA details limited population pathway for antibiotics in new guidance, Regulatory Focus 13 June 2018).
Much of the guidance remains unchanged from the draft version, though FDA has made clarifications and added examples throughout the document.
In the final guidance, FDA further clarifies how it interprets “limited population” by contrasting two examples of drugs, one that would be fit for the LPAD pathway and one that would not.
“For example, an antibacterial drug that would have a role in the preventative armamentarium for only a select patient population (e.g., mechanically ventilated patients) with no other options may be an appropriate candidate for the LPAD pathway; in contrast, an antibacterial drug intended for broad population-level prevention of an infrequently or rarely occurring serious or life-threatening disease generally would not be an appropriate candidate,” FDA explains.
FDA adds an example to the section of the guidance on approval of drugs under the LPAD pathway to explain that it will not approve products under the pathway when they can be approved via traditional or accelerated approval pathways.
“For example, a drug for which the sponsor conducts a streamlined development program may be eligible for traditional approval if the clinical data support approval in a broader population,” FDA writes.
The guidance also makes changes to the language used in the example labeling sections to remove a line stating that only limited clinical data are available for the drug in question.
FDA guidance now directs sponsors to the agency’s guidance on developing antibacterial products for patients with an unmet medical need for insights on streamlined development programs and says the concepts presented in that guidance “are applicable to drugs that are eligible for the LPAD pathway.”
Additionally, the agency notes that sponsors seeking approval for multiple indications should specify which indications are proposed for approval under the LPAD pathway. Sponsors seeking approval for multiple indications, not all of which are proposed for approval under the LPAD pathway, are instructed to consult the review division handling the application for advice on incorporating LPAD pathway-related information into the labeling.
Lastly, the final guidance expands on the sections covering promotional material to add new information about what applicants should do to meet the pre-dissemination requirements for LPAD pathway drugs and explains how sponsors can request to terminate LPAD pathway limitations via an efficacy supplement when additional clinical data would support the use of a drug in a broader population.