Roche's Esbriet, Boehringer Ingelheim's Ofev win FDA approval for idiopathic pulmonary fibrosis

The FDA on Wednesday cleared Roche's Esbriet (pirfenidone) and Boehringer Ingelheim's Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF), marking the first approvals for this indication in the US. Esbriet was granted breakthrough therapy status for the treatment of IPF in July, along with Boehringer Ingelheim's therapy. Both drugs have also been awarded fast track, priority review and orphan drug status.

According to the US regulator, the safety and efficacy of Esbriet were supported by data from three clinical studies involving a total of 1247 patients with IPF. The ASCEND trial, which was conducted at the behest of the FDA after the regulator declined to approve the drug in 2010, showed that the drug significantly reduced disease progression versus placebo after one year of treatment.

Meanwhile, the approval of Ofev was backed by data from three clinical studies including 1231 patients with IPF. In study results presented earlier this year at the American Thoracic Society conference, the kinase inhibitor was found to reduce the annual rate in decline of forced vital capacity after 52 weeks of treatment in the INPULSIS-1 and INPULSIS-2 trials.

A Genentech spokesman said that Esbriet will be priced at roughly $94 000 annually, while a spokeswoman for Boehringer Ingelheim said that the price of Ofev will be disclosed after the therapy is launched, which is expected to occur within the next 10 days. Commenting on the news, Cowen & Co. analyst Ritu Baral suggested that the high proportion of patients who experienced diarrhea while taking Ofev could "relegate the drug to de facto second-line use." Meanwhile, Leerink analysts previously projected sales of $1.6 billion for Esbriet by 2020 and $3 billion by 2030.

Esbriet was previously cleared in Europe and Canada for the treatment of mild to moderate IPF. Roche gained rights to the therapy in its $8.3-billion takeover of InterMune in August.

For related analysis, see ViewPoints: Roche's aggressive bid for InterMune may be sign of its bullishness on expanding use of pirfenidone. See also ViewPoints: Roche confident of backing right horse in IPF race.

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