FDA approves two competing 'breakthrough' IPF drugs in one day

October 16, 2014 2:58 PM

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FDA approves two competing 'breakthrough' IPF drugs in one day

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 som...

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