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Glaxo/Innoviva's Triple Combo Therapy Gets FDA Nod for COPD

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GlaxoSmithKline plc (GSK - Free Report) and partner Innoviva, Inc. (INVA - Free Report) announced that the FDA has approved a once-daily, single inhaler triple combination therapy — FF/UMEC/VI (fluticasone furoate/umeclidinium/vilanterol) — as maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). The drug is approved under the brand name, Trelegy Ellipta. The company said that the medicine will be available in the United States shortly.

While fluticasone furoate is an inhaled corticosteroid (ICS), umeclidinium is a long-acting muscarinic antagonist (LAMA) and vilanterol is a long-acting beta2-adrenergic agonist (LABA). This combination medicine will be delivered once daily in the Ellipta dry powder inhaler. Typically, the ICS/LAMA/LABA amalgamation for advanced COPD is delivered via two or more inhalers with potentially differing dose regime. However, GlaxoSmithKline’s triple therapy combination offers a daily treatment in a single Ellipta inhaler.

Notably, closed triple combination therapy is not licensed as a single inhaler triple therapy anywhere outside the United States.

GlaxoSmithKline’s shares are up 4% so far this year, comparing unfavorably with the 16.4% rally of the industry during the period.

 

We remind investors that in November last year, GlaxoSmithKline and Innoviva announced filing of a regulatory submission for the triple combination therapy in the United States for the given indication. Good news is that the regulatory application was submitted around 18 months earlier than expectations.

Additionally, last December, GlaxoSmithKline and Innoviva had filed regulatory applications for the combination therapy in the EU.

The filing was based on data from the closed triple combination therapy development program as well as results of the phase III FULFIL study on FF, UMEC and VI, either alone or in combination. The study revealed superiority of the closed triple combination over Symbicort Turbohaler in improving lung function and health-related quality of life in COPD patients.

Good news is that this month, European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the combination treatment.

Notably, the combination therapy is also under assessment across a number of other 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.

Zacks Rank & Stocks to Consider

GlaxoSmithKline currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharma sector are Aduro Biotech, Inc. (ADRO - Free Report) and ACADIA Pharmaceuticals Inc. (ACAD - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aduro Biotech’s loss per share estimates reduced from $1.46 to $1.32 for 2017 and from $1.41 to $1.24 for 2018 over the last 60 days. The company delivered positive surprises in two of the trailing four quarters with an average beat of 2.53%.

ACADIA’s loss per share estimates narrowed from $2.82 to $2.57 for 2017 and from $2.07 to $1.90 for 2018 over the last 60 days. The company came up with positive earnings surprises in two of the last four quarters with an average beat of 7.97%.

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