The FDA has issued a final guidance for industry, Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment. Early localized disease occurs within one month after a tick bite and is characterized by erythema migrans (EM), a rash at the site of the bite that may be accompanied by nonspecific symptoms (e.g., fatigue, muscle pain). Early disseminated disease occurs days to months after the tick bite and is characterized by multiple EM lesions, often away from the bite site, as well as potential neurologic and cardiac symptoms.
This final guidance describes FDA’s current recommendations on drug development considerations for the treatment of early Lyme disease (i.e., early localized and early disseminated disease), including trial population, trial design, safety, and efficacy among other considerations.
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