Breathe Deeply: Did Insmed Release Dodgy Data For Its Drug?

Deciphering trial data can be a fascinating pastime, especially when the findings indicate a medication is truly capable of making a difference for patients. Other times, however, this activity can cause consternation if the results suggest something may be awry. Such may be the case with Phase III data released the other day by Insmed for its Arikace antibiotic for cystic fibrosis sufferers. The drugmaker released a poster presentation showing that its experimental medication demonstrated statistical non-inferiority compared with an existing Novartis (NVS) treatment, which is another way of saying that Arikace was equally effective. However, the findings suggest that the presentation may present a skewed picture, according to The Street. How so? The drugmaker noted the number of patients who were enrolled and randomized into the study, the so-called intent to treat group. But the chart that was used to illustrate the results for the primary endpoint, which measured lung function over 24 weeks, relied on a slightly different population known as per protocol that excluded more two dozen patients (see Figures 3 and 4 in the poster). As The Street notes, this prompts some questions, given that analyzing an intent-to-treat population is usually a more conservative approach and the findings from the per protocol population indicate that Arikace was “just barely positive.” The suggestion is that, had Insmed relied on the intent-to-treat population, its drug may not have achieve...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs