Approval decision on Yutrepia for PH-ILD expected in January
Liquida seeks FDA OK to extend therapy's use to 2nd indication
Amid ongoing litigation, the U.S. Food and Drug Administration (FDA) has agreed to review an application from Liquidia that seeks to extend the approval of Yutrepia — an inhaled dry powder formulation of treprostinil — to cover pulmonary hypertension associated with interstitial lung disease (PH-ILD).
The FDA in 2021 granted Yutrepia tentative approval for the treatment of pulmonary arterial hypertension (PAH). If approved, the extension would cover the therapy also for PH-ILD, which refers to high blood pressure in the lungs that develops due to diseases that cause scarring of lung tissues.
“If this amendment is approved by FDA, Yutrepia would be indicated for the treatment of both PH-ILD and pulmonary arterial hypertension (PAH),” Rajeev Saggar, MD, Liquidia’s chief medical officer, said in a company press release.
A decision from the FDA on the extension for PH-ILD is expected by Jan. 24. If the extension is approved, it would come into effect after the end of an exclusivity period granted to the inhaled treprostinil therapy Tyvaso. Litigation is ongoing between Liquida and United Therapeutics, which markets Tyvaso.
Litigation remains ongoing between 2 therapy developers
Treprostinil is a vasodilator, a medication that lowers blood pressure by prompting blood vessels to relax and widen. Several formulations of treprostinil are FDA-approved for use in PAH and PH-ILD. Among them are the oral formulation Orenitram, the infusion/injection Remodulin, and the inhaled formulation Tyvaso.
All three of these formulations of the medication are sold by United, which has sued Liquidia over allegations that Yutrepia — like Tyvaso, an inhaled formulation of treprostinil — violates several of United’s patents covering Tyvaso.
The FDA’s prior decision to give Yutrepia tentative approval for PAH means that the therapy already has met safety and efficacy standards needed for its approval. However, formal approval allowing the therapy to be sold in the U.S. cannot be given until the ongoing litigation with United is finalized.
We are pleased that the FDA has accepted the submission for review with [an expected decision] date well in advance of the expiration in March 2024 of the new clinical investigation exclusivity granted to Tyvaso.
An approved extension, if granted, would come into effect March 31 — after the expiration of a new clinical investigation exclusivity that was granted to Tyvaso and protects the medication from market competition for a set period of time.
“We are pleased that the FDA has accepted the submission for review with [an expected decision] date well in advance of the expiration in March 2024 of the new clinical investigation exclusivity granted to Tyvaso,” Saggar said.
The FDA’s tentative approval of Yutrepia for PAH was based on data from the open-label INSPIRE clinical trial (NCT03399604). Results showed that the treatment improved exercise ability and life quality in adults with PAH and was generally well tolerated.
Liquidia sought the extension of Yutrepia’s approval to cover PH-ILD following written confirmation from the FDA that no additional clinical data is needed to support a potential positive decision. The company also reiterated at the time that it believes United’s patents for Tyvaso are invalid and/or not infringed by Yutrepia.