Novartis' inhaler for COPD gets FDA approval

Utibron Neohaler--Courtesy of Novartis

Novartis ($NVS) announced FDA approval last week of its Utibron Neohaler as a long-term maintenance treatment for COPD via the delivery of the bronchodilating agents indacaterol and glycopyrrolate.

In addition, the agency approved the use of glycopyrrolate inhalation powder as a monotherapy, which will be delivered using the Seebri Neohaler. Both combination products will hit the market in early 2016, according to a company release.

The approval comes after a trial of 2,654 patients with COPD that consisted of two 12-week efficacy studies and a 52-week safety study, the release notes. Novartis notes that the approval does not cover asthma, and Utibron is not meant to replace rescue inhalers for sudden attacks.

"Patients have told us about the tremendous impact their COPD can have on everyday activities," said Christi Shaw, Novartis' U.S. country head, in a statement. "With this approval, the COPD community now has a new medicine that can help so many patients by improving not only their symptoms, but also their health-related quality of life. This means the possibility of doing things that matter to them."

Novartis says the Neohaler line of inhalers generates low resistance during delivery, making it easy to use.

Patients are instructed to insert a Utibron capsule inside the inhaler and then pierce it by squeezing buttons on the side of the device. Then, patients must put their mouth on the mouthpiece, inhale and hold their breath for 5 to 10 seconds. Once the capsule is empty of powder (this could take more than one breath), it's time to finish the 13-step process by removing the capsule from the inhaler, according to the product website.

Unfortunately, proper breathing technique and usage of inhalers have been shown to be challenging for patients, making simplification a drug delivery challenge for the future.

Novartis says almost 27 million Americans have COPD, making it the third leading cause of death in the U.S. Novartis hopes to grab a large share of a market expected to reach $14 billion by 2018.

The Utibron will compete with GlaxoSmithKline's ($GSK) Anoro and Breo Ellipta, as well as Boehringer's Stiolto Respimat in the combination drug COPD arena.

- read the release
- here's FierceBiotech's take