Shares of Theravance Biopharma, Inc. (TBPH - Free Report) rallied 5.3% on positive opinion from the Committee for Medicinal Products for Human Use (“CHMP”), the scientific committee of the European Medicines Agency (“EMA”), for the label expansion of GlaxoSmithKline’s (GSK - Free Report) COPD drug, Trelegy Ellipta. Glaxo is seeking approval for Trelegy Ellipta in a broader patient population who are not adequately treated by a long-acting muscarinic antagonist (“LAMA”) and long-acting beta2-agonist (“LABA”). Theravance has economic interest in the drug and earns royalties on its sales.
The label expansion application will also include data about effect on exacerbations from the IMPACT study in the drug’s label.
The positive CHMP opinion for Trelegy Ellipta was originally received by Glaxo and its partner Innoviva, Inc. (INVA - Free Report) on Sep 21.
Trelegy Ellipta, a triple combination therapy of inhaled corticosteroid (ICS)/LAMA/LABA (fluticasone furoate/umeclidinium/vilanterol 'FF/UMEC/VI'), is already approved as maintenance treatment for COPD patients who are not adequately treated by a combination of ICS and a LABA.
Theravance’s stock has increased 9.6% so far this year compared with the industry’s increase of 2.6%.
Data from the IMPACT study showed that Trelegy Ellipta is superior to ICS/LABA combination, Relvar/Breo Ellipta, or LAMA/LABA combination, Anoro Ellipta, on multiple endpoints including reduction in exacerbations and improving lung function in moderate to severe COPD patients.
Last week, Theravance along with its partner Mylan (MYL - Free Report) announced positive new data from the phase III program on Yupelri (revefenacin) inhalation solution evaluating it in COPD patients. Data from the clinical studies showed that treatment with Yupelri for up to 52 weeks resulted in reduction in rates of chronic obstructive pulmonary disease (COPD) exacerbations, ranging from 15% to 18%, in moderate to very severe COPD patients compared to placebo and Spiriva HandiHaler.
The candidate is under review in the United Sates with a decision expected later in November. A tentative approval of Yupelri will boost Theravance’s growth prospects and reduce its dependence on its sole marketed product, Vibativ.
Theravance currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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