The U.S. Food and Drug Administration (FDA) has accepted for review the new drug application (NDA) Liquidia Technologies submitted earlier this year requesting marketing approval of LIQ861, its proprietary inhaled dry powder formulation of treprostinil, for treating pulmonary arterial hypertension (PAH).
The U.S. agency has set a Prescription Drug User Fee Act (PDUFA) action date for Nov. 24. By then, it will decide whether to approve LIQ861 for this indication.
LIQ861 is an experimental dry powder formulation of the vasodilator treprostinil, that is intended to widen blood vessels in the lungs and lower blood pressure. LIQ861 is based on Liquidia’s PRINT technology that enables the production of highly uniform drug particles with controlled size, shape, and chemical properties.
PRINT was used to enhance and optimize LIQ861’s deep-lung delivery in PAH patients. The medication is inhaled through a user-friendly, portable, dry powder inhaler.
“FDA acceptance of this NDA is a significant milestone for our company and our PRINT technology. PRINT was the cornerstone that allowed for the precise engineering and development of LIQ861 into its current form, and serves as the foundation for all of our products in development,” Neal Fowler, CEO of Liquidia, said in a press release.
“If approved, LIQ861 will represent an important step forward in addressing the unmet needs of PAH patients by providing a convenient alternative to existing therapies. We look forward to working closely with the FDA through the NDA review process,” Fowler said.
The application Liquidia submitted to the FDA was supported by positive data from three clinical trials, including the open-label Phase 3 INSPIRE trial (NCT03399604), which assessed the safety, tolerability, and pharmacokinetic properties (how a therapy is absorbed, distributed, metabolized, and eliminated from the body) of LIQ861.
Liquidia’s application has been submitted under the 505(b)(2) regulatory pathway, which allows that at least part of the information required for regulatory approval, such as the safety and effectiveness of the medication’s active ingredient, to come from studies not carried out by and for the candidate’s sponsor.
Compared to the more traditional 505(b)(1) route that requires all data to be obtained from studies conducted by and for the applicant, the 505(b)(2) regulatory pathway can speed up the approval process.
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