United Therapeutics' (UTHR) Tyvaso DPI NDA Gets CRL From FDA
Zacks Investment Research | Oct 18, 2021 10:29PM ET
United Therapeutics (NASDAQ:UTHR) industry ’s 16.9% decline.
Following the CRL, the company anticipates that the FDA’s query regarding the deficiency can be resolved quickly and it can obtain approval for Tyvaso DPI in the United States by the summer of 2022.
The drug-device product offers some benefits over nebulized Tyvaso Inhalation Solution, which is already approved in the United States for the treatment of PAH and PH-ILD. Tyvaso DPI 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.
If approved, United Therapeutics expects Tyvaso DPI to double the number of patients on Tyvaso by 2022.
United Therapeutics has developed Tyvaso DPI in collaboration with MannKind. The FDA did not report any deficiencies in its CRL with regard to operations at MannKind's device manufacturing and testing facility for Tyvaso DPI.
Please note that United Therapeutics filed the NDA for Tyvaso DPI earlier this year in April with a priority review voucher. The FDA accepted the NDA and granted priority review to the NDA in June 2021.
Please note that United Therapeutics is a market leader in PAH medicines. Other than Tyvaso, which is an inhaled version of treprostinil, the company markets three other PAH medicines in the United States — Remodulin, an injectable formulation of treprostinil approved for both subcutaneous and intravenous use; Orenitram, an oral version of treprostinil; and Adcirca tablets. United Therapeutics bought exclusive rights to commercialize Adcirca (tadalafil) for PAH in the United States from Eli Lilly .
Xencor’s earnings per share estimates for 2021 have narrowed from $0.75 to $0.33 in the past 60 days. The same for 2022 has narrowed from $3.14 to $2.92 over the same period.
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