Liquidia seeks extension of Yutrepia’s tentative OK for PH-ILD
The inhaled form of treprostinil already is approved for PAH
Liquidia is seeking to extend the tentative approval of Yutrepia, an inhaled dry powder formulation of treprostinil for pulmonary arterial hypertension (PAH), to include pulmonary hypertension associated with interstitial lung disease (PH-ILD).
PH-ILD occurs when blood pressure in the lungs is high due to a disease that causes lung scarring.
The request, submitted as an amendment to a new drug application (NDA), follows written confirmation from the U.S. Food and Drug Administration (FDA) that no additional clinical data are required, the company noted.
“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,” Roger Jeffs, PhD, CEO of Liquidia, said in a press release.
“This feedback reinforces our undeterred commitment to deliver on the full potential of YUTREPIA to improve patients’ lives,” he added.
In parallel with the amendment, Liquidia recertified that patents covering Tyvaso, the inhaled treprostinil formulation by United Therapeutics, are invalid and/or not infringed by Yutrepia.
In response to Liquidia’s first application for Yutrepia, previously known as LIQ861, the FDA requested more data on the therapy and the device used for its administration. An updated application was submitted in May 2021.
In June 2020, United filed a lawsuit against Liquidia for alleged infringement of three patents related to Tyvaso. In November 2021, Yutrepia’s NDA was granted tentative approval, which means the therapy met all regulatory requirements for approval in terms of safety and effectiveness. However, patent infringement allegations precluded its full approval, which allows for commercial use.
According to Liquidia, all patents previously asserted by United Therapeutics were deemed invalid or not infringed.
If accepted, the approval for PH-ILD will come into effect on March 31, 2024, the date when a clinical investigation exclusivity granted to Tyvaso expires. Exclusivity provides the holder of an approved therapy, in this case United, limited protection from new competition in the marketplace.
Tentative approval based on INSPIRE trial data
FDA’s tentative approval of Yutrepia was based on data from a Phase 3 open-label clinical trial called INSPIRE (NCT03399604), which showed that Yutrepia was safe and well tolerated, and improved exercise capacity and quality of life in adults with PAH.
Treprostinil is a vasodilator — a substance that prompts blood vessels to relax and widen, thus lowering blood pressure. Besides Tyvaso, treprostinil is available in an oral formulation as Orenitram and given in an infusion/injection as Remodulin, also marketed by United. Tyvaso DPI, a dry powder, inhaled formulation of treprostinil, was approved by the FDA in May 2022 for people with PAH or PH-ILD.
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