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EMA validates Solithera for CABP
The European Medicines Agency has validated a marketing authorization application for the approval of Solithera, an oral and IV treatment for community-acquired bacterial pneumonia, according to a release from the drug’s manufacturer.
Solithera (solithromycin, Cempra) is a novel next-generation macrolide that has shown potent activity against macrolide-resistant strains of pneumonia. This validation formally begins the review process for solithromycin, which, if approved, would be the first new oral and IV antibiotic available in the European Union in more than 15 years, according to the release.
“With increasing failure rates of primary antibiotic therapy and increasing hospitalization rates due to CABP in the EU, there is an urgent need for new, safe and effective oral and IV antibiotic therapies,” Prabhavathi Fernandes, PhD, president and CEO of Cempra, said in the release. “The validation of Cempra’s [marketing authorization application] brings solithromycin another step closer to meeting this need in the EU, and we look forward to continuing to work closely with the EMA through the review process.”
Two phase 3 trials reported within the past year have indicated the efficacy of solithromycin. SOLITAIRE-Oral, demonstrated oral solithromycin’s noninferiority to moxifloxacin therapy among patients with identified Mycoplasma pneumoniae infection (early clinical response absolute difference, 0.29%; 95% CI, –5.5 to 6.1). More recently, SOLITAIRE-IV demonstrated similar outcomes between IV-to-oral solithromycin and moxifloxacin regimens (early clinical response absolute difference, – 0.46; 95% CI, –6.1 to 5.2), regardless of macrolide resistance.
“For [community-acquired pneumonia (CAP)], there really haven’t been any new oral drugs for use in the community — telithromycin and moxifloxacin were really the only two in the last 15 years, but neither of these were useful in pediatric populations,” Brian D. Jamieson, MD, senior director of clinical research at Cempra, told Infectious Disease News. “[Solithromycin would] be the first new antibiotic for CAP in about 25 years that will have pediatric suspension, IV and oral formulations.” – by Dave Muoio
References:
Barrera CM, et al. Lancet Infect Dis. 2016;doi:10.1016/S1473-3099(16)00017-7.
Sheets A, et al. Abstract Saturday-467. Presented at: ASM Microbe; June 16-20, 2016; Boston.
Disclosure: Fernandes and Jamieson are employees of Cempra