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Glaxo Files for COPD Drug; FluLaval Approved for Infants

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GlaxoSmithKline plc (GSK - Free Report) and partner Innoviva, Inc. (INVA - Free Report) announced filing of a regulatory submission in the U.S. for a once-daily, closed triple combination therapy (fluticasone furoate, FF/umeclidinium, UMEC/vilanterol, VI) for chronic obstructive pulmonary disease (COPD). Encouragingly, the company submitted a regulatory application for the therapy around 18 months earlier than its expectations.

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). The combination medicine will be delivered once daily in the Ellipta dry powder inhaler. Typically, th ICS/LAMA/LABA combinations for advanced COPD are delivered via two or more inhalers with a potentially differing dose regime. However, Glaxo’s triple therapy combination offers a daily treatment in a single Ellipta inhaler.

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.

Glaxo intends to submit a regulatory filing in the EU in the coming weeks, which will likely be followed by submissions in other countries beginning in 2017.

In a separate press release, Glaxo announced that it has received approval from the FDA’s Center for Biologics Evaluation and Research for a label expansion of its vaccine FluLaval Quadrivalent (Influenza Vaccine) for use in children aged 6 months and older. Prior to this, the vaccine was approved only for the treatment of patients aged 3 years and above as active immunization against influenza.

The supplemental Biologics License Application (sBLA) was based on a pivotal phase III study and three supportive clinical studies conducted in children aged 6 months to 35 months of age.

Currently approved quadrivalent influenza vaccines include AstraZeneca’s (AZN - Free Report) intranasalinfluenza vaccine FluMist Quadrivalent and Sanofi’s (SNY - Free Report) quadrivalent formulation of Fluzone.

According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 20,000 children under the age of 5 years are hospitalized due to influenza complications. This means that an approval in this expanded indication will allow it to launch the first quadrivalent (four-strain) flu vaccine in the US.

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