FDA Provides Draft Guidance on Early Lyme Disease Drug Development
A new FDA draft guidance for sponsors developing drugs to treat early Lyme disease focuses on trial designs for treatment of erythema migrans, a rash that often appears as one of the first symptoms in the disease’s early stages.
The guidance advises sponsors to conduct two adequate, well-controlled randomized double-blind trials that do not use placebos, but notes that in some cases, robust findings from a single trial supported by other independent clinical and/or nonclinical data may be sufficient for demonstrating effectiveness to the FDA.
Trials should enroll participants who have early localized (a single rash lesion) or early disseminated (multiple rash lesions) disease and have resided in or traveled to a Lyme disease-endemic area. Generally, patients with musculoskeletal, neurologic or cardiac manifestations of the disease should not be enrolled.
Trials also should not enroll patients with ongoing symptoms attributed to a history of Lyme disease or another tick-borne infection, such as babesiosis, ehrlichiosis or anaplasmosis, the agency advises.
The draft guidance does not touch on general issues in statistical analysis or trial design. It also doesn’t discuss pharmacology/toxicology or clinical pharmacology for Lyme disease drugs in development, as considerations in these areas are similar to other anti-infective drugs, the FDA says.
Read the full draft guidance here: https://bit.ly/3wWLGhL.
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