FDA promises a fast review for Boehringer's lung disease contender
The FDA is guaranteeing a priority review for Boehringer Ingelheim's much-watched treatment for a rare lung disease, likely speeding up the drug's path to market as the German pharma races with biotech InterMune ($ITMN).
Boehringer's treatment, dubbed nintedanib, is a therapy for idiopathic pulmonary fibrosis (IPF), an often fatal disease that scars the lungs and stands in the way of oxygen absorption. In two Phase III studies on more than 1,000 patients, the drug reduced patients' annual rate of lung-function decline by 48% and 55%, compared to just 5% with placebo.
In the U.S., there are no approved treatments for IPF, which kills about 40,000 people a year, according to the Coalition for Pulmonary Fibrosis. The FDA's priority review designation for nintedanib will give Boehringer wider access to regulators and a faster path to a final decision, under agency rules, a regulatory victory that should come in handy as the company strives to hit the U.S. market before an encroaching rival.
Pirfenidone, InterMune's competing IPF drug, endured an FDA rejection in 2010, but, thanks to promising new Phase III studies, the biotech has worked its way back into the good graces of investors. InterMune resubmitted the treatment in May and expects to win approval within 6 months, launching pirfenidone in the first quarter of 2015 if all goes according to plan.
Boehringer isn't disclosing its planned timeline for nintedanib, but even if InterMune wins the stateside race, the company has to like its commercial chances. Pirfenidone is already on the market in Europe, but, despite two years of momentum, the drug brought in just $70.2 million last year. The European Medicines Agency last month agreed to an accelerated review of nintedanib, and Boehringer, with its commercial heft, should be able to compete if and when it launches nintedanib on the continent.
Analysts have said the U.S. market for IPF treatments could peak at north of $2 billion, but just which company will claim the largest share of it remains up for debate. InterMune's shares shot up in March after Boehringer revealed that nintedanib missed a secondary endpoint in one of its Phase III trials, but a May editorial in The New England Journal of Medicine heralded the drug's efficacy and potential as a new hope for IPF patients.
- here's the release
Boehringer, InterMune wow IPF field with a slate of groundbreaking trial data
Boehringer's lung disease drug hits the EU fast track in a race with InterMune
InterMune rockets up after scoring a big win on PhIII lung drug study