Saturday, April 20, 2024

Legal Clash Over Pharmaceutical Application: United Therapeutics Sues FDA Over Rival Liquidia’s Approval

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In a rare legal maneuver, United Therapeutics has initiated legal action against the FDA, alleging that the regulatory body deviates from established protocols by allowing competitor Liquidia to submit a pharmaceutical application directly competing with United’s Tyvaso product. The lawsuit contends that the FDA erred in permitting Liquidia to circumvent longstanding regulatory procedures and guidelines governing the handling of pending pharmaceutical approval applications.

Central to the legal dispute is Liquidia’s pursuit to broaden the scope of its Yutrepia product, a formulation of treprostinil administered via a dry powder inhaler (DPI), to encompass the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). This strategic amendment aims to supplement Yutrepia’s current new pharmaceutical application (NDA), which originally targeted the management of pulmonary arterial hypertension (PAH).

Liquidia’s initiative to extend the therapeutic indication of Yutrepia underscores its ambition to address a broader spectrum of pulmonary vascular disorders beyond its initial focus on PAH. By leveraging existing clinical data and regulatory pathways established for PAH treatment, Liquidia aims to expedite the pharmaceutical application approval process for its product in addressing the unmet medical needs of patients with PH-ILD.

This amendment represents a proactive approach by Liquidia to maximize the therapeutic potential of Yutrepia and capitalize on emerging clinical evidence suggesting its efficacy in treating PH-ILD. By integrating PH-ILD into the label of Yutrepia, Liquidia seeks to position its product as a versatile and comprehensive solution for various pulmonary hypertension subtypes, thereby enhancing its market competitiveness and commercial viability.

However, United Therapeutics’ legal challenge raises questions about the regulatory implications of expanding Yutrepia’s label to encompass PH-ILD. United contends that such an amendment may circumvent established regulatory protocols and precedents governing the approval process for new drug indications. Moreover, United asserts that Liquidia’s actions may undermine the principles of fair competition and intellectual property rights established under the Hatch-Waxman Act, potentially disadvantaging innovator companies like United.

A Legal Battle Shaping the Future of Pulmonary Hypertension Treatment and Pharmaceutical Innovation

The dispute between United and Liquidia underscores the complex interplay between regulatory compliance, competitive dynamics, and innovation in the pharmaceutical industry. As both companies navigate the legal proceedings, the outcome of this case may have far-reaching implications for future pharmaceutical applications and market access strategies within the pulmonary hypertension therapeutics landscape.

United’s Tyvaso, which also utilizes treprostinil and is available in both DPI and nebulizer formulations, has held FDA approval for treating PH-ILD since 2021, in addition to its clearance for PAH dating back to 2009. Notably, Tyvaso’s DPI variant stands as the company’s leading revenue generator, raking in $731 million in sales last year, representing nearly one-third of its total revenues.

While Yutrepia secured tentative FDA approval for PAH in 2021, its launch has been stalled due to an ongoing patent infringement lawsuit initiated by United. Per the Hatch-Waxman Act, such litigation triggers a 30-month stay on full FDA approval or until the legal dispute is resolved.

Pharmaceutical Application

United Therapeutics’ Standoff with FDA Over Liquidia’s Fast Pharmaceutical Application Process

United asserts that by permitting Liquidia to pursue PH-ILD as an amendment to its existing new pharmaceutical application rather than filing a new application, the FDA has effectively enabled Liquidia to bypass the 30-month stay mechanism triggered by pending patent litigation. The FDA, originally slated to announce its decision on Yutrepia’s PAH indication last month, postponed its ruling to address the amendment and has refrained from setting a new deadline.

United contends that before 2021, every clinical trial evaluating pharmaceuticals approved for PAH treatment in the context of PH-ILD failed, with some therapies exacerbating symptoms. Tyvaso emerged as the inaugural therapy approved for PH-ILD, demonstrating efficacy in United’s INCREASE clinical trial, conducted at significant expense. United contends that Liquidia is leveraging Tyvaso’s innovation to expedite its market entry, yet argues that Liquidia must first address the patent infringement claim against it before proceeding to market.

Dean Bunce, United’s head of global regulatory affairs, asserts, “We are simply asking that the FDA apply its own rules and precedents consistently to honor the Hatch-Waxman balance struck by Congress between innovators and imitators.” The lawsuit underscores the significance of adhering to established regulatory frameworks and maintaining equity between innovators and competitors in the pharmaceutical landscape.

 

Resource: Pharmaphorum, February 22, 2024

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