With patent concerns looming, Roche gets a new priority review on blockbuster IPF drug
Seven years after the FDA first approved Esbriet, the blockbuster Roche IPF drug is getting an expedited review for a second indication.
On Thursday, the agency gave Esbriet priority review for unclassified interstitial lung diseases, or forms of pulmonary inflammation and scarring that don’t fit easily into the over 200 known types of ILD. The move comes 10 months after Esbriet received breakthrough designation and sets Roche up for a decision by May.
The Swiss pharma is bidding for a new indication at an acute period for their longtime blockbuster. One of two major idiopathic pulmonary fibrosis drugs alongside Boehringer Ingelheim’s Ofev, Esbriet continues to bring over $1 billion per year. But sales growth has slowed, particularly in the US, and the company’s orphan designation protections in IPF begin to expire this year.
With that deadline looming, Roche has sought to guard against would-be generics, filing around a dozen lawsuits to stop Teva, Sandoz and others from releasing cheaper, copycat versions of the drug. Esbriet’s annual wholesale cost is around $100,000.
Roche acquired Esbriet in their $8.3 billion buyout of the California biotech InterMune, two months before the FDA would give the drug a green light. The agency had initially rejected the drug in 2010, demanding InterMune run a second Phase III trial.
The Big Pharma, though, would not put the drug into a pivotal trial for unclassifiable interstitial lung disease until 2017. In 2019, investigators published Phase II results from 253 unclassifiable ILD patients, showing patients who took the drug had significantly more stable lung function, as measured by an endpoint called forced vital capacity.
The new indication is just one route Roche is using to try to keep its fibrosis franchise alive. The company has also invested in finding a new blockbuster for IPF, acquiring Promedior and its pipeline of anti-fibrotic molecules for up to $1.4 billon in 2019. The lead drug, which has received breakthrough designation, went into Phase III earlier this year.
So far, Roche has stayed ahead of Boehringer in that search; two months after Roche started their Phase III, the German pharma dropped out of its own $1 billion fibrosis pact, citing toxicity with their partner’s drug.