Lefamulin Designated QIDP and Fast Track Status for Bacterial Infections

Nabriva Therapeutics announced that the Food and Drug Administration (FDA) has designated lefamulin as a Qualified Infectious Disease Product (QIDP) and has been granted Fast Track status for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

RELATED: Nosocomial Pneumonia Agent Designated Fast Track Status

Nabriva plans to initiate Phase 3 clinical studies with lefamulin. If approved, lefamulin will be the first of a new class of antibiotics available for the treatment of community-acquired bacterial pneumonia (CABP), hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), and acute bacterial skin and skin structure infections (ABSSSI), with potential in several other indications (eg, sexually transmitted infections including MDR gonorrhea, osteomyelitis) including pediatric uses.

For more information visit Nabriva.com.

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