PARI Pharma has received European marketing authorization for its Vantobra 170 mg tobramycin/1.7 ml inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis patients aged 6 and older, the company said. Vantobra is delivered via the Tolero nebulizer and is packaged together with the device. PARI Pharma submitted the marketing authorization application for the product in July 2012.
According to PARI Pharma, Vantobra typically has 4 minute treatment times compared to 15 minutes for TOBI. The company noted that the EMA’s Committee for Medicinal Products for Human Use (CHMP) also found Vantobra to be “clinically superior to the orphan medicinal product TOBI Podhaler due to greater safety in a substantial portion of the target population.”
PARI Pharma President Martin Knoch commented, “When PARI Pharma developed customizable eFlow Technology, our hope was to reduce nebulization time while delivering full medicinal benefits. Vantobra’s highly concentrated tobramycin solution along with Tolero’s drug-specific eFlow technology combine technological advancements. This is science working for patients. Vantobra delivered via the Tolero is PARI Pharma’s first approved drug/device combination and joins a suite of other novel medicines delivered via customizable eFlow technology in development with our pharmaceutical partners or already on the market, such as Gilead’s Cayston.”
Read the PARI Pharma press release.
Read the EMA assessment report on Vantobra.
