New Products

Several CEOs and 17 years later, Melinta scores an FDA OK for its antibiotic

 

Eugene Sun, CEO, Melinta

It’s taken 17 years and a long chain of CEOs, but privately held Melinta Therapeutics has nabbed an FDA approval for its antibiotic delafloxacin, which can now be sold as Baxdela.

Melinta announced a little more than a year ago that the antibiotic had proven non-inferior to vancomycin for acute bacterial skin and skin structure infections (ABSSSI). The last switch up in the executive suite at Melinta, once called Rib-X, was when Mary Szela— now CEO of Novelion — was replaced by R&D chief Eugene Sun in 2015.

Baxdela is a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including MRSA, in both oral and IV forms.

Melinta is one of a few late-stage developers in this space, looking to address the growing demand for new antibiotics in a world of growing drug resistance. Zavante touted its own win in April, prepping an FDA application. Paratek hit a few days ahead of that biotech. But Cempra has had a major setback to deal with.

The field has its attractions, but it’s not easy, which explains an absence of many large pharma players on the R&D side. There are a number of cheap, generic antibiotics available for frontline use. And any new antibiotic is going to face an uphill battle gaining traction in this market.

The approximately 3 million patients hospitalized each year in the U.S. with ABSSSI often present treatment challenges owing to their underlying medical conditions, making optimal antibiotic selection difficult. Baxdela provides a treatment option for adult patients with ABSSSI based on its coverage spectrum, IV and oral dosing flexibility, efficacy and safety profile,” said Sun in a prepared statement. “The approval of Baxdela demonstrates FDA’s commitment to making new and effective antibiotics available to address unmet needs for hospitalized ABSSSI patients.


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RAPS Regulatory Convergence 2017