Arikace Noninferior for Pseudomonas Infection in Cystic Fibrosis

July 01, 2013

(Reuters) - Insmed Inc's experimental lung infection drug fared no better than a competing drug developed by Novartis AG in a lung function test.

Insmed's drug, Arikace, was being tested as a treatment for Pseudomonas lung infection in cystic fibrosis patients.

Insmed said in a statement that the trial met its main goal of showing that Arikace was not inferior to the competing drug.

But a presentation posted on Insmed's website showed that patients taking Arikace displayed a smaller improvement in lung capacity than those on TOBI, Novartis's drug for the same infection.

The difference was narrow enough for Arikace to meet its "primary endpoint of non-inferiority compared with twice-daily TOBI."

Arikace, a treatment inhaled once daily, showed a lower mean change in forced expiratory volume in one second than the twice-daily TOBI.

The late-stage study, which included 302 patients and was conducted at 70 sites in Europe and Canada, reported adverse events consistent with those seen in similar studies.

Insmed Chief Executive Will Lewis said the company would file for regulatory approval for Arikace in Canada and Europe during the first half of 2014.

Insmed is also testing Arikace in a mid-stage study for non-tuberculous mycobacteria (NTM) lung disease. The company said Arikace received a fast-track designation from the U.S. Food and Drug Administration on June 28.


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