Vantobra By PARI Pharma Received Marketing Authorization In Europe for Cystic Fibrosis

Vantobra By PARI Pharma Received Marketing Authorization In Europe for Cystic Fibrosis

PARIVantobra® by PARI Pharma is a novel, highly concentrated tobramycin nebulizer solution for inhalation delivered by a Tolero® nebuliser that received a Marketing Authorization granted by the European Commission in March. Vantobra offers treatment times of approximately 4 minutes for cystic fibrosis patients, with outcomes comparable to TOBI®, as concluded by the Committee for Medicinal Products for Human Use (CHMP). The CHMP also concluded that Vantobra is clinically better than orphan product TOBI Podhaler® due to its safety profile in a significant portion of the population targeted.

“In clinical trials, patients were able to take a full treatment of Vantobra within 4 minutes. This is a major benefit for cystic fibrosis patients that have been used to 15-minute treatment times with TOBI and already have a long list of other therapies. Saving time and making it easier for patients is a major goal for PARI. We believe that reducing the treatment burden leads to increased adherence to antibiotic therapy and addresses a key issue for patients and physicians,” explained Dr. Oliver Denk, PARI Pharma’s vice president.

Martin Knoch, PARI Pharma’s President added: “When PARI Pharma developed customisable eFlow Technology, our hope was to reduce nebulisation 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 customisable eFlow technology in development with our pharmaceutical partners or already on the market, such as Gilead’s Cayston®.”

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In two different clinical studies, both Vantobra and TOBI revealed comparable efficacy and safety profiles. The most relevant difference between the two therapeutics is the treatment time for patients. Vantobra requires twice per day treatments with more than 10 hours of inhalation time each month that can be saved when compared to TOBI. Vantobra also presents a fast and very well-tolerated alternative to tobramycin dry powder inhalation.

Given the fact that cystic fibrosis patients must invest hours of their daily life into taking medication, using medical devices, and undergoing other therapies in order to maintain optimal health, PARI is confident that TOBI’s efficiency will continue to help improve qualify of life for people with the disease.

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