Liquidia Corporation announced that it has submitted an sNDA for its Yutrepia treprostinil DPI, which was tentatively approved by the FDA in November 2021 for the treatment of pulmonary arterial hypertension (PAH). The supplemental application is for the use of Yutrepia to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). According to the company, the FDA has indicated that no additional clinical data will be required for the PH-ILD indication.
Yutrepia is currently the subject of patent litigation brought by United Therapeutics alleging infringement of patents covering Tyvaso treprostinil inhalation solution. Liquidia notes that all patents covering Tyvaso have been found by either the courts or by the Patent Trial and Appeal Board (PTAB) to be either invalid or not infringed by Yutrepia and says that the sNDA contains a paragraph IV certification to that effect. The company also notes that FDA final approval would take at least until the expiration of Tyvaso’s new clinical investigation exclusivity, which will expire at the end of March, 2024.
Liquidia CEO Roger Jeffs commented, “We have submitted this request to ensure that patients may access Yutrepia for both the PAH and PH-ILD indications as soon as possible. We continue to hear from the community that alternative inhaled products are needed, especially for those patients who may benefit from a low resistance dry powder inhaler that can be easily titrated to optimal therapeutic effect like Yutrepia. This feedback reinforces our undeterred commitment to deliver on the full potential of Yutrepia to improve patients’ lives.”
Read the Liquidia press release.
