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Biotech Stocks Facing FDA Decision In August 2020

GlaxoSmithKline
GlaxoSmithKline

GlaxoSmithKline plc (GSK) has sought expanded FDA approval for its once-daily, single-inhaler triple-therapy device Trelegy Ellipta in the indication of asthma in adults, and a decision is expected in August.

Trelegy Ellipta is a combination of three molecules - Fluticasone furoate, an inhaled corticosteroid, Umeclidinium, a long-acting muscarinic antagonist, and Vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta dry powder inhaler. It is jointly developed by GSK and Innoviva Inc. (INVA).

Theravance Biopharma is entitled to receive an 85% economic interest in the royalties paid by GSK on worldwide net sales of Trelegy Ellipta, as part of an agreement with Innoviva.

Trelegy Ellipta is already approved by the FDA for the treatment of patients with chronic obstructive pulmonary disease.

Global annual sales of Trelegy Ellipta were £518 million in 2019 compared to £156 million in 2018.

GSK closed Friday’s (Jul.24, 2020) trading at $40.29, down 0.02%.