Boehringer Ingelheim's Ofev and Roche's ($RHHBY) Esbriet became the first two U.S.-approved treatments for idiopathic pulmonary fibrosis (IPF) when the FDA green-lighted them on the same day last month. And while Roche has the lead with Esbriet in Europe, Boehringer is now one step closer to leveling the playing field on the continent.
On Friday, the German pharma announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended the treatment for approval, a nod it based on results from Phase III results from the company's INPULSIS trial.
"There has been a high unmet need for effective treatments that can slow disease progression in IPF," Klaus Dugi, Boehringer's chief medical officer, said in a statement. "We look forward to making nintedanib available soon to patients with IPF in the EU."
|BI CMO Klaus Dugi|
Now, Boehringer will wait for a verdict from the EMA, which has granted Ofev accelerated assessment. And if the body follows CHMP's advice, the company can start chipping away at the lead Esbriet has built since winning European approval back in 2011.
In the meantime, BI will keep plugging away to try to gain some ground in the U.S. As part of those efforts, the company is fielding a team of 100 to 200 sales reps and associated nursing professionals to get the word out, as well as offering copay assistance and a patient support program for the $96,000 orphan drug, U.S. CEO Paul Fonteyne told FiercePharma in October.
But Roche, too, has a similar program in place for $94,000 Esbriet, "designed to help with access, financial support and ongoing education," it said in a statement.
- read the release
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