Savara’s AeroVanc gets orphan drug designation in US

According to Savara Pharmaceuticals, the company’s AeroVanc inhaled vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients has been granted orphan drug status by the FDA. Aerovanc inhalation powder, which is delivered using a capsule-based DPI, has completed Phase 1 trials, and Savara says that it is preparing its first Phase 2A study.

Savara CEO Robert Neville commented, “Orphan drug designation in combination with our 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. 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.’”

Read the Savara press release.

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