Glaxo (GSK) Files For U.S. Label Expansion Of COPD Inhaler

GlaxoSmithKline plc (NYSE:GSK) along with partner Innoviva, Inc. (NASDAQ:INVA) announced that they have submitted a supplemental new drug application (sNDA) to the FDA for label expansion of its once-daily single inhaler triple therapy, Trelegy Ellipta.

The company is looking to expand the label to be used as a maintenance therapy for treatment of airflow obstruction and reduction of exacerbations in patients with chronic obstructive pulmonary disease (“COPD”). The company is also expecting to submit regulatory filing for the expanded indication in the EU and other countries in 2018.

Trelegy Ellipta received an FDA approval in September and the EU approval came about this November. It is presently approved for the treatment of moderate-to-severe COPD in patients, already under treatment with a combination of inhaled corticosteroid and a long-acting beta2-adrenergic agonist (“LABA”) but require additional bronchodilation.

Notably, Trelegy Ellipta is a combination of fluticasone furoate — an ICS, umeclidinium — a long-acting muscarinic antagonist (LAMA) and vilanterol, a LABA therapy.

Shares of GlaxoSmithKline are down 9% so far this year, comparing unfavorably with the 14.8% rally of the industry it belongs to.

The submission of sNDA was based on positive data from phase III IMPACT study. The trial evaluated Trelegy Ellipta in comparison to the dual therapies of Anoro Ellipta (UMEC/VI) and Relvar/Breo Ellipta (FF/VI). The study showed triple therapy’s superiorityover the dual combo therapies on multiple endpoints, including exacerbation rates, lung function and health-related quality of life.

It is important to note that the combination treatment is also under assessment across countries including Australia and Canada.

Per the company’s press release, COPD is a progressive serious lung disease, commonly found to affect approximately 384 million people worldwide, representing a significant need for such therapies. Moreover, the label expansion of Trelegy Ellipta will provide the company with access to a wider patient-population base, suffering from different challenges of COPD.

Zacks Rank & Key Picks

GlaxoSmithKlinecarries a Zacks Rank #3 (Hold). Two better-ranked stocks in the health care sector are Ligand Pharmaceuticals Inc. (NASDAQ:LGND) and Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Ligand’s earnings per share estimates have moved up from $3.68 to $3.70 for 2018 over the last 30 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 8.22%. Share price of the company has surged 30.7% year to date.

Achillion’s loss per share estimates have narrowed from 65 cents to 63 cents for 2017 and from 74 cents to 67 cents for 2018 over the last 30 days. The company came up with positive earnings surprises in two of the trailing four quarters with an average beat of 4.51%.

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