FDA approves two competing 'breakthrough' IPF drugs in one day
- Two FDA breakthrough treatments—Roche/InterMune's Esbriet (pirfenidone) and Boehringer Ingelheim's Ofev (nintedanib)—are now approved for patients with idiopathic pulmonary fibrosis, an often fatal, lung-scarring disease.
- Idiopathic lung disease kills 40,000 people every year. Until yesterday, the only therapies available for the disorder were oxygen therapy, pulmonary rehabilitation, and lung transplant.
- Both drugs were approved based on phase 3 data showing significantly reduced forced vital capacity (FVC).
Thanks to having not one, but two new treatment options, many IPF patients will now be able to take themselves off of the lung transplant waiting list. This approval is good news for patients, as well as Boehringer and Roche (which acquired Esbriet maker InterMune this past summer)—analysts predict a $2 billion annual market for this condition.
Until the week, IPF represented a serious unmet medical need. As such, both Esbriet and Ofev received fast-track, priority review, orphan product, and breakthrough designations. The drugs both had strong phase 3 data, with strong FVC results. The only downside is that each drug is accompanied by some side effects that could be bothersome, including gastrointestinal side effects, insomnia, and weight loss. Nonetheless, IPF patients now have treatment options designed to improve the quality and length of their lives.
The big question now is: who will win the marketing war between Roche and Boehringer?