20th Feb 2026 13:11
(Alliance News) - PureTech Health PLC said on Friday its drug treating idiopathic pulmonary fibrosis, deupirfenidone, has been designated as an orphan drug by both the US Food & Drug Administration and the European Commission.
Orphan drug designations are granted for drugs treating rare and life-threatening conditions, as their development would not be financially viable otherwise.
Such designations come with financial benefits such as tax credits and fee reductions, and 7 years of market exclusivity in the US, which is extended to 10 in the EU.
Unexplained pulmonary fibrosis is a progressive, fatal lung disease with a median survival time after diagnosis of two years, affecting less than 5 in 10,000 people.
Deupirfenidone is being advanced by Celea Therapeutics, a PureTech subsidiary.
The Boston-based biotherapeutics firm said results from phase 2b testing show the drugs appear to suggest it slows "lung function decline to a level that more closely mirrors healthy ageing, without compromising tolerability".
Celea's Chief Executive Officer Sven Dethlefs said: "Orphan drug designation further validates both the seriousness of this disease and the importance of advancing our program, which we believe has the potential to redefine treatment expectations for patients living with IPF."
A phase 3 trial is expected to begin in the first half of 2026. If successful, the company said, it could complete the data package required from registration.
PureTech shares were up 1.6% to 126.20 pence each on Friday afternoon in London.
By Martin Miraglia, Alliance News reporter
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