Innoviva Wins Another Key FDA Approval for Asthma

The U.S. Food and Drug Administration (FDA) has approved Innoviva Inc.’s (NASDAQ: INVA) treatment of asthma and for patients with chronic obstructive pulmonary disease (COPD), the company announced, giving shares a boost early Thursday.

Specifically, the FDA has approved Innoviva’s Trelegy Ellipta for the treatment of asthma patients aged 18 years and older, adding to its current license for use in patients with COPD.

The approval means Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD and is the only single inhaler triple therapy available for patients in a convenient once-daily inhalation in the United States.

This approval was based on a supplemental New Drug Application (sNDA) that included data from the Captain study, showing that in patients uncontrolled on inhaled corticosteroids/long-acting beta agonist (ICS/LABA), the additional bronchodilation provided by Trelegy demonstrated significant improvements in lung function.

In a sense, Trelegy’s approval for the maintenance treatment of asthma in patients 18 and older yields a new paradigm for managing about 30% of adult asthma patients who still experience symptoms despite being adherent to ICS/LABA combination therapy.

Management noted that Trelegy was approved in the United States in 2017 as the first once-daily single inhaler triple therapy for the treatment of COPD, and it remains the market leader. However, this approval in asthma is another significant step in the treatment of respiratory diseases.

Innoviva stock traded up 4% early Thursday at $12.19, in a 52-week range of $7.58 to $15.62. The consensus price target is $8.00.

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