The FDA has listed Kitabis™ Pak as an equivalent therapy to TOBI® (tobramycin inhalation solution, USP) in their “Orange Book” (an FDA-published guideline for equivalent therapies). Kitabis Pak is listed under the “AN” designation, which means there are no suspected or known bio-equivalence issues between TOBI and Kitabis Pak that can negatively impact the health of those with cystic fibrosis.
“It makes sense that the FDA listed Kitabis Park as therapeutically equivalent in the Orange Book, because TOBI was developed as tobramycin inhalation solution delivered with the PARI LC PLUS® nebulizer,” said the portfolio manager for Kitabis Pak at PARI, Jan Zimmermann. “One prescription for Kitabis Pak ensures access to both tobramycin inhalation solution and the PARI LC PLUS nebulizer handset, co-packaged and dispensed together. In addition, PARI initiated a compressor access program called PARI PROVIDE that is administered through a network of specialty pharmacies.”
The New Drug Application for Kitabis Pak was approved by the FDA last December 2, 2014. The Kitabis Pak sets a new standard among nebulized drugs in which both the nebulizer handset and the drug and are co-packed in the same way as asthma inhalers; the drug and the device are dispensed and prescribed together. The drug’s price is similar to the price of tobramycin, the generic drug.
“Our definitive goal is to ensure that patients with cystic fibrosis who are prescribed tobramycin inhalation solution also get the nebulizer handset that was used in clinical trials and approved for use with TOBI. Kitabis Pak accomplishes this goal and makes it easy for patients since they come together in an easy to understand kit,” said the director of PARI’s Medical Science & Pharmaceutical Alliances, Lisa Cambridge.
The FDA’s Orange Book was published for the first time in 1980 to address the requests from states for a list of already approved and equivalent drugs that might help in making choices concerning what can reduce the costs of drugs.
Cystic fibrosis is a life-threatening disease that affects almost 30,000 individuals in the United States. It is caused by a genetic alteration (mutation) which leads to thickened mucus secretions and poorly hydrated lungs. It can also affect the pancreas, kidney, liver and the intestines.