United Therapeutics (NASDAQ: UTHR) continues its quest to grow its commercial product line with a new application to regulators.
The Silver Spring company said Monday it has submitted its application to the Food and Drug Administration for Tyvaso DPI, an inhaler that dispenses a dry powder form of pulmonary arterial hypertension drug treprostinil. The biotech seeks the go-ahead to take the product to market four months after buying a priority review voucher to accelerate the regulatory review process.
That voucher positions UT to receive a decision from the FDA by December, UT said in its release, though the agency would first have to accept the application and give the company a formal decision date.
Tyvaso DPI, if approved, would serve an addressable U.S. market of at least 75,000 patients. That includes 45,000 PAH patients, plus roughly 30,000 additional patients with interstitial lung disease — which causes scarring of the lungs and hinders breathing — who currently have no treatment options. And it would “enable patients to go about their day with just a small breath-actuated, dry powder inhaler that easily fits inside a pocket and requires no batteries or external power source to operate,” Dr. Gil Golden, chief medical officer of United Therapeutics, said in a statement.
An approval would contribute to the company’s goal of doubling the number of patients using Tyvaso therapies by the end of 2022, Michael Benkowitz, its president and chief operating officer, said in a statement. And that’s critical to the biotech’s income, as sales of its existing Tyvaso formulation increased 16% year-over-year to $483.3 million in 2020.
That UT is advancing Tyvaso DPI also reflects its need to innovate in other areas, as its top-selling drug, Remodulin, saw sales wane 12% to $516.7 million in 2020, due largely to generic competition and Covid-19, according to the company.
Such competition also stands to threaten the future of Tyvaso, after UT settled patent litigation with Watson Laboratories Inc. in August 2018. That Parsippany, New Jersey company sought to market a generic version of Tyvaso in the U.S. and post-settlement, has the OK to launch its drug in January 2026 or earlier under certain circumstances, UT said in filings with the Securities and Exchange Commission.
The Maryland drugmaker’s products that use treprostinil — Remodulin, Tyvaso and Orenitram — still accounted for nearly $1.3 billion in sales last year, according to SEC filings. United Therapeutics closed 2020 with $1.48 billion in net revenue, as its patient base using treprostinil therapies hit an all-time high in the fourth quarter.
United Therapeutics has developed Tyvaso DPI with Westlake Village, California-based MannKind Corp. (NASDAQ: MNKD), following a license agreement the parties signed in 2018.
Tyvaso, which opens the blood vessels in the lungs so more blood can flow into them, first earned market approval in 2009 to improve exercise ability for PAH patients. In early April, UT also got the green light for Tyvaso Inhalation Solution, an inhaled form of treprostinil, to increase exercise ability in patients with pulmonary hypertension from interstitial lung disease.
Earlier this year, United Therapeutics started selling Remunity, another delivery system for flagship PAH drug Remodulin. It’s also working toward launching its implantable system for Remodulin that was previously delayed. On treprostinil, the company is now studying its inhaled form for other uses, while expanding beyond its core PAH business and into the pulmonary fibrosis space.
