After missing its Jan. 24 PDUFA date, the regulator has extended its review period but has not issued a new decision timeframe or requested additional data, Liquidia announced Thursday.
Pictured: Delayed stamp and imprint in red ink/iStock, Olivier Le Moal
Liquidia remains stuck in regulatory limbo as the FDA extended its review period for Yutrepia’s New Drug Application. The company announced Thursday in an update that the regulator missed its Jan. 24 PDUFA goal date and the agency’s review remains ongoing.
Shares of Liquidia were down 10% in premarket trading upon the announcement.
The North Carolina-based biopharma has been on a long journey with its inhaled powder drug indicated for the treatment of pulmonary arterial hypertension (PAH)—high blood pressure in the lungs. PAH is a rare, progressive and chronic disease that causes hardening and narrowing of the pulmonary arteries.
Yutrepia (treprostinil) was granted tentative approval from the FDA in November 2021. In September 2023, the FDA accepted for review the amendment of the NDA to add pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the label.
Liquidia’s single product has also been held up in court due to a patent battle with United Therapeutics’ Tyvaso, which prevented the drug from being marketed in the United States. Last month, a federal circuit affirmed the voiding of a patent for Tyvaso, clearing the way for Yutrepia’s approval. Tyvaso totaled $883 million in sales for the first three quarters of 2023.
Despite the FDA not being able to issue an action letter in time to meet the Jan. 24 PDUFA date, the regulator has not requested additional clinical data, the company said in Thursday’s announcement. Nor has the agency issued a new PDUFA goal date.
“Whether the NDA is amended or supplemented, we will continue to prepare for the final FDA approval of Yutrepia to treat both PAH and PH-ILD patients following the expiration of regulatory exclusivity for Tyvaso on March 31, 2024,” Liquidia CEO Roger Jeffs said in a statement.
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.
