Roche: FDA Grants Breakthrough Therapy Designation for Esbriet
March 03 2020 - 1:53AM
Dow Jones News
By Cristina Roca
Roche Holding AG said Tuesday that the U.S. Food and Drug
Administration has granted breakthrough therapy designation to
Esbriet for adults with unclassifiable interstitial lung
disease.
The FDA granted the designation based on data from a phase II
trial, which suggested that Esbriet slowed disease progression in
patients with the disease, the Swiss pharmaceutical company
said.
"Breakthrough therapy designation is a process designed to
expedite the development and review of drugs that are intended to
treat a serious condition," according to the FDA's website.
Esbriet is already approved for the treatment of idiopathic
pulmonary fibrosis, and has been designated an orphan medicine in
Europe. It is an oral medicine.
Write to Cristina Roca at cristina.roca@dowjones.com;
@_cristinaroca
(END) Dow Jones Newswires
March 03, 2020 01:38 ET (06:38 GMT)
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