United Therapeutics (UTHR) Tyvaso DPI Gets FDA's Priority Tag
United Therapeutics UTHR announced that FDA has accepted and granted priority review to its a new drug application (NDA) seeking approval of its drug device combination therapy, Tyvaso dry powder inhaler or Tyvaso DPI.
The NDA is seeking approval of Tyvaso DPI for both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) indications. The FDA’s review is expected to be completed in October 2021 with a decision expected soon thereafter. However, the FDA approval of the NDA is subject to the agency’s inspection of the Tyvaso DPI manufacturing facility operated by MannKind,which is expected to be completed in the third quarter of 2021.
United Therapeutics has developed Tyvaso DPI in partnership with MannKind Corporation MNKD. Tyvaso DPI comprises the dry powder formulation of United Therapeutics’ PAH medicine, Tyvaso (treprostinil)and a small, portable, dry powder inhaler. The drug-device product offers some benefits over nebulized Tyvaso Inhalation Solution. It is expected to be less time-consuming to administer and more mobile and convenient.
The NDA filing was based on data from the BREEZE study, which met its primary objective of demonstrating safety and tolerability of Tyvaso DPI in PAH patients who transitioned from nebulized Tyvaso Inhalation Solution. In addition, a pharmacokinetic (PK) study in healthy volunteers demonstrated comparable treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution.
United Therapeutics had filed the NDA in April this year with a priority review voucher (PRV). United Therapeutics had acquired a Rare Pediatric Disease PRV in January 2021. The PRV was redeemed upon submission of the Tyvaso DPI NDA in April.
United Therapeutics’ stock has risen 20.9% this year so far against the industry’s decrease of 8.7%.
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Other than Tyvaso, which is an inhaled version of treprostinil, United Therapeutics markets three other PAH medicines in the United States. Remodulin, an injectable formulation of treprostinil; Orenitram, an oral version of treprostinil; and Adcirca tablets. Remodulin is approved for both subcutaneous (SC) and intravenous (IV) use. Please note that United Therapeutics bought exclusive rights to commercialize Adcirca (tadalafil) for PAH in the United States from Eli Lilly LLY in November 2008. Eli Lilly markets tadalafil as Cialis for erectile dysfunction. Adcirca/Cialis lost exclusivity in 2018 and generic versions are available.
United Therapeutics is working on several late-stage PAH studies. Key phase III programs include Tyvaso in PAH patients who have chronic obstructive pulmonary disease (COPD) (PERFECT study), Tyvaso in patients with various forms of chronic fibrosing interstitial lung disease (TETON studies) and Ralinepag (PAH — ADVANCE studies). The first TETON study in patients with idiopathic pulmonary fibrosis (IPF) is expected to enroll its first patients in the second quarter of 2021.
United Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked small drugmaker is Cumberland Pharmaceuticals CPIX. It has Zacks Rank #2 (Buy).
Cumberland’s stock has risen 3.4% this year so far. Its earnings estimates for 2021 have increased from breakeven to 8 cents per share while that for 2021 have risen from 5 cents per share to 10 cents per share over the past 60 days.
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