By Liquidia, a pharmaceutical company, experienced a decline in premarket trading following an announcement that the U.S. Food and Drug Administration (FDA) is still reviewing its application for an inhalation powder designed to treat pulmonary arterial hypertension. The shares saw a decrease of 10% and were valued at $10.86.
Although the FDA has not requested additional clinical data, Liquidia revealed that the extended review of its new drug application for Yutrepia (also known as treprostinil) has caused a delay beyond the anticipated goal date of January 24th.
In an effort to expand the drug’s treatment capabilities, Liquidia modified its new drug application last July to include pulmonary hypertension associated with interstitial lung disease. This decision was made after receiving tentative approval in November 2021 for treating pulmonary arterial hypertension.
To address this amendment, the FDA has informed Liquidia that it is currently verifying the process for incorporating the indication for pulmonary hypertension associated with interstitial lung disease into the Yutrepia application.
Roger Jeffs, the Chief Executive of Liquidia, assured that the company is actively communicating with the FDA regarding the application amendment process and the addition of this indication.
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