FDA adcom support puts Paratek's antibiotic closer to approval
- An expert panel advising the Food and Drug Administration has thrown its support behind a new antibiotic aimed at treating two kinds of infection.
- In a 17-1 vote, the Antimicrobials Drug Advisory Committee recommended approval of Paratek Pharmaceuticals' omadacycline for acute bacterial skin and skin structure infections (ABSSSI). It also recommended the drug gain approval for community-acquired bacterial pneumonia (CABP) in a 14-4 vote.
- The drug is a tetracycline that Paratek tweaked so it can handle tetracycline-resistant microbes. The drug is available in both oral and intravenous formulations, and in Phase 3 testing showed a similar safety and efficacy profile to linezolid and moxifloxacin in treating ABSSSI and CABP, respectively.
The FDA isn't required to follow advisory committee suggestions, but it usually does. The chances of that happening are even more likely for omadacycline, given how intent the agency is on getting new antibiotics to market.
Fueling that fire are antibiotic-resistant microbial infections that kill about 23,000 people in the U.S. every year, according to the Centers for Disease Control and Prevention. Just last month, FDA head Scott Gottlieb said the agency is trying to better incentivize antibiotic drug development, including implementing a new infectious disease classification offering certain drugs fast track and priority review designations, as well as five additional years of exclusivity.
"Despite the growing incidence of these resistant strains of bacteria, there has unfortunately been an overall decline in antibiotic drug research driven largely by the significant obstacles to developing innovations in this category. This is especially true when it comes to developing new antibiotics that work through novel mechanisms that can evade existing patterns of resistance," Gottlieb said.
To Gottlieb's point, reports surfaced in July that Novartis was ending antibacterial and antiviral research and eliminating nearly 150 jobs in the process. Allergan, AstraZeneca and The Medicines Co. have also backed away from infectious disease in the past few years.
Paratek, meanwhile, plans to forge ahead with omadacyline and its other asset Seysara (sarecycline). Both are under review at the FDA, and an approval decision for the former should come in early October.
Investment bank Leerink predicts omadacyline sales will reach $500 million by 2023, yet also expects regulators will require a post-marketing study for CABP given that one Phase 3 trial had more patient deaths in the treatment arm than the active comparator.
"The public comments of infectious disease and emergency room doctors at today's meeting reinforce our conviction," Leerink analyst Ami Fadia wrote in an Aug. 8 note. "The small positive move in the stock reflects that a positive Adcom was largely expected."
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