InterMune secured the FDA’s breakthrough therapy designation for its in-development treatment of a rare lung disease, evening the regulatory score with rival Boehringer Ingelheim as the two angle for position on the US market.
The biotech’s drug, pirfenidone, treats the often-fatal idiopathic pulmonary fibrosis (IPF), a lung-scarring disease that inhibits oxygen absorption, leading to shortness of breath and poor pulmonary function. The FDA’s breakthrough tag guarantees an expedited review and access to the agency’s senior staff, but InterMune isn’t expecting the nod to change the drug’s timeline for approval.
Pirfenidone already picked up the FDA’s promise of a priority review, and the addition of a breakthrough designation doesn’t dial up the agency’s speed, InterMune said in an email. That said, the FDA’s promise to “involve senior FDA managers and provide additional resources to coordinate cross-disciplinary review” could make a difference in time, but that’s entirely at the agency’s discretion, InterMune said.
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