BioCentury
ARTICLE | Clinical News

FDA approves Melinta's Baxdela for ABSSSIs

June 23, 2017 7:11 PM UTC

FDA approved oral and IV Baxdela delafloxacin (RX-3341) from Melinta Therapeutics Inc. (New Haven, Conn.) to treat acute bacterial skin and skin structure infections (ABSSSIs). Baxdela’s label includes a boxed warning that notes the risks of serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy and CNS effects. Melinta said the broad-spectrum fluoroquinolone antibiotic is active against both Gram-positive and Gram-negative pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).

Melinta plans to launch Baxdela in 4Q17. The therapy has Fast Track and Qualified Infectious Disease Product (QIDP) designations from FDA to treat ABSSSIs and community-acquired bacterial pneumonia (CABP), and was under Priority Review for ABSSSIs...