European Commission Authorizes PARI’s Vantobra for CF Patients

Pharmaceutical company PARI Pharma received marketing authorization from the European Commission for its nebulizer Vantobra, a breakthrough therapy for patients who suffer from cystic fibrosis (CF). The product is a novel and highly concentrated tobramycin therapeutic option for inhalation that uses a Tolero nebulizer, and will now be commercialized in the European Union.

The Committee for Medicinal Products for Human Use (CHMP) analyzed the breakthrough nebulizer solution Vantobra and confirmed its ability to decrease treatment times to four minutes, as well as its treatment outcomes similar to TOBI. In addition, CHMP decided to take into consideration the clinical superiority of Vantobra compared to TOBI Podhaler in terms of safety, as announced by the company in a press release.

“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,” explained the vice president of PARI, Oliver Denk. “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.”

The proprietary aqueous solution Vantobra provides 170 mg tobramycin/1.7 ml for inhalation through an optimized, drug-specific Tolero nebulizer handset, which are packaged together. Vantobra and Tolero were developed by PARI for the management of chronic pulmonary infections caused by Pseudomonas aeruginosa. The therapy is indicated for CF patients older than six years and it is now approved only in Europe.

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“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,” stated the president of PARI Pharma, Martin Knoch.

“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,” added Knoch.

The similar safety and efficacy profiles of Vantobra and TOBI was revealed in two different clinical trials, which also demonstrated that the greatest difference is in time it takes to administer treatment. By conducting treatment two times a day with Vantobra, patients are able to save over 10 hours of inhalation therapy times monthly, in comparison to TOBI. This is significant to people with CF, since they already have to spend a great deal of time daily maintaining their health through taking medication and other treatments. In addition, Vantobra also offers an alternative to tobramycin dry powder inhalation.

PARI also recently started enrolling CF patients in its compressor access program called PARI PROVIDE, designed to support the launch of the Kitabis Pak. The product includes a combination of a drug and the device, which has already received approval from the U.S. Food and Drug Administration (FDA) and is expected to become the first co-packaging of generic tobramycin inhalation solution to use a PARI LC PLUS Nebulizer.