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news.The US Food and Drug Administration (FDA) has granted orphan drug designation to Savara Pharmaceuticals' first inhaled antibiotic, designed for the treatment of pulmonary methicillin-resistant Staphylococcus aureus (MRSA) infection in cystic fibrosis (CF) patients.
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The antibiotic, AeroVanc, is a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration.
In Phase I studies, AeroVanc was well tolerated in healthy volunteers and CF patients and demonstrated an excellent pharmacokinetic profile.
Savara Pharmaceuticals chief executive officer Robert Neville said orphan drug designation in combination with the company’s intellectual property provides strong market exclusivity potential for AeroVanc.
"We hope to provide similar benefits to MRSA infected patients that tobramycin provides for the treatment of Pseudomonas aeruginosa infections," Neville added.
"The response from the cystic fibrosis community has been very encouraging, so much so that physicians like to refer to AeroVanc as the ‘TOBI for MRSA’ ."
Rainbow Babies and Children’s Hospital and Case Western Reserve University pediatrics department chairman Michael Konstan said in the absence of an FDA approved inhaled antibiotic therapy directed at MRSA, CF clinicians are increasingly prescribing off-label nebulization of the intravenous formulation of vancomycin.
"This therapy is generally well tolerated, has high antibacterial activity against MRSA, and patients have a good clinical response," Konstan added.
The company is also currently preparing for its Phase IIa clinical study to be carried out at 20 CF centers in the US to demonstrate AeroVanc’s efficacy.