Roche tipped to lead Boehringer in IPF head-to-head
Patients in the US with serious lung disease idiopathic pulmonary fibrosis (IPF) have gone from no approved drugs to two after the FDA cleared products from Roche and Boehringer Ingelheim.
The green lights for Roche's Esbriet (pirfenidone) - acquired as part of its $8.3bn deal to acquire InterMune earlier this year - and Boehringer's Ofev (nintedanib) represent the first alternative to oxygen therapy, pulmonary rehabilitation, and lung transplant for the estimated 128,000 IPF patients in the US.
IPF is a progressive scarring of the lungs, leading to shortness of breath, cough and - in extreme cases - can lead to fatal complications such as heart failure. Esbriet has been on the market in Europe since 2011, but the US approval for Ofev is the first for the drug anywhere in the world.
Both drugs have been awarded breakthrough status by the FDA and have been approved to treat patients with milder forms of IPF, which account for up to 50,000 cases.
According to the FDA, the safety and efficacy of Esbriet were backed by data from three clinical studies involving a total of 1,247 patients. The pivotal trial for the drug - called ASCEND - was carried out after the regulator turned down InterMune's marketing application 2010. A recently-completed pooled analysis of data from the trials revealed a 52% reduction in lung function decline and/or death after a year's treatment.
Similarly, Ofev was supported by data from three clinical studies including 1,231 IPF patients, once again revealing a significant decline in the lung function after 52 weeks of treatment.
Roche has indicated it will launch its product within a few days and has placed the price tag at $94,000 a year, while Boehringer has not yet gone public with pricing plans but said its product would also be available shortly.
Analysts expect Ofev to be priced similarly to Esbriet, but JP Morgan has suggested Esbriet will eventually become the most popular choice, largely because a sizeable number of Ofev-treated patients experience diarrhoea.
Another key factor will be whether Esbriet's claimed survival benefit is included in the label, although the FDA's press statement makes no mention of a mortality claim. JP Morgan said recently Esbriet should rack up $1.4bn or more in peak sales, while Goldman Sachs suggested Roche's drug would capture around 60 per cent of the IPF drug market.
Meanwhile, both the new drugs could face competition in future from Genoa Pharmaceuticals' inhaled version of pirfenidone - in Phase 3 testing - as well as a series of drugs in Phase II IPF trials including Bristol-Myers Squibb's BMS-986020, AstraZeneca's tralokinumab, Gilead Sciences' simtuzumab, Biogen Idec's STX-100 and FibroGen's FG-3019.