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Biotech Stocks Facing FDA Decision In April 2021

United Therapeutics
United Therapeutics

The FDA decision to expand the label of United Therapeutics Corp.’s (UTHR) Tyvaso Inhalation Solution for the treatment of pulmonary hypertension associated with interstitial lung disease is expected in April 2021.

Tyvaso Inhalation Solution was approved by the FDA for the treatment of pulmonary arterial hypertension in July 2009.

Pulmonary hypertension refers to high blood pressure in the lungs and is estimated to affect at least 15% of patients with interstitial lung disease (ILD).

Interstitial lung disease (ILD) is a group of lung diseases in which marked scarring occurs within the lungs. It is often complicated by pulmonary hypertension. Patients with both interstitial lung disease and pulmonary hypertension are more likely to have a worse course of disease and worse survival rate than patients with interstitial lung disease alone. Currently, there is no FDA-approved therapy to treat this serious, life-threatening disease.

Tyvaso generated annual sales of $483.3 million compared to $415.6 million in 2019.

UTHR closed Friday’s (Mar.26, 2021) trading at $171.21, up 1.70%.