The FDA will make its decision on Baxdela for use in community-acquired bacterial pneumonia by October 24.
Baxdela (delafloxacin) from Melinta Therapeutics is a newer fluoroquinolone antibiotic that received approval from the U.S. Food and Drug Administration (FDA) in 2017 for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The approval was based on clinical data that showed Baxdela to be safe and effective against both gram-positive and gram-negative pathogens, including MRSA.
Recently, the FDA granted Melinta priority review for its application to expand the indications for Baxdela to treatment of community-acquired bacterial pneumonia (CAPB). The agency will make its decision by October 24, 2019.
Gaining approval of new antibiotics takes a long time –– 17 years in the case of Baxdela. In addition, prices for antibiotics tend to be low, and they are often only viable for a limited time due to the development of resistance. The financial rewards are minimal as a result, and many pharma companies have exited the space to focus on other more lucrative indications. Most R&D in the antibiotic field is, therefore, being conducted by small/emerging biopharma firms. A new system is needed to encourage companies to participate in new antibiotic development, such as a more value-based pricing approach.