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Corporate News Blog - GlaxoSmithKline and Innoviva’s Trelegy Ellipta Gets Marketing Authorization for the Treatment of COPD in Europe

LONDON, UK / ACCESSWIRE / November 20, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for GlaxoSmithKline PLC (NYSE: GSK) ("GSK"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=GSK. The leading research-based pharmaceutical and healthcare Company, announced on November 16, 2017, with Innoviva Inc. (NASDAQ: INVA), a pharmaceutical Company focused on bringing compelling new medicines to patients in areas of unmet need, that the European Commission (EC) has granted marketing authorization to the Trelegy Ellipta therapy for the treatment of adult patients with moderate to severe chronic obstructive pulmonary disease (COPD), and who are not satisfactorily treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. This decision follows the positive recommendation from the European Medicines Agency (EMA) for Trelegy Ellipta in September 2017. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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Chronic Obstructive Pulmonary Disease (COPD), a life Challenging Condition

  • COPD is a progressive lung disease, which is caused by long-term exposure to inhaled irritants that damage the lungs and airways. These irritants include cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes, or dust from the environment.
  • It is estimated that COPD currently affects around 384 million people worldwide. The symptoms for COPD generally begin at 40 years or above.
  • COPD has several life challenging implications as the inability to breathe normally can hamper basic day-to-day activities such as walking up stairs.

Trelegy Ellipta Therapy for Treating COPD

  • Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, ‘FF/UMEC/VI') is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA), delivered once daily in GSK's Ellipta dry powder inhaler.
  • So far, it is the first once-daily single inhaler triple therapy to be approved in Europe. The licensed strength as delivered is FF/UMEC/VI 92/55/22 mcg.
  • On September 18, 2017, the drug was approved for use in the US for the long-term, once-daily, maintenance treatment of patients with COPD, including chronic bronchitis and/or emphysema. Trelegy Ellipta is advised for patients who are already on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and decreasing exacerbations and need additional treatment, or those patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.
  • Trelegy Ellipta received the marketing authorization from the EC on November 16, 2017, and the first European launch is expected to take place by the end of 2017.
  • Besides, regulatory applications have also been submitted in a number of other countries and are currently under assessment.

Basis for the European Marketing Authorization

  • The European Marketing Authorization for Trelegy Ellipta is primary based on the efficacy and safety data from the FF/UMEC/VI development program, and the data from various studies that have evaluated the components alone or in combination.
  • The results of the Phase-3 FULFIL study (which stands for Lung Function and quality of LiFe assessment in COPD with closed trIpLe therapy), which examined once-daily single inhaler triple therapy compared to twice-daily budesonide/formoterol were declared in June 2016 and published in 2017 (Lipson DA et al. Am J Resp Crit Care Med 2017).

An Important Development in the Treatment of COPD

Eric Dube, Senior Vice President & Head at GSK Global Respiratory Franchise, shared that COPD is a serious lung disease, which affects millions of people worldwide. Its symptoms aggravate over time with many patients also experiencing frequent debilitating exacerbations. For treating this condition, a combination of different types of medicines is required. According to Dube, Trelegy Ellipta is the first medicine to be approved in Europe that delivers three effective molecules in a once-daily single inhalation, and he considers this to be an important innovation in COPD management. Dube and his team look forward to making Trelegy Ellipta available for patients suffering from COPD.

Currently, about one fourth of COPD patients are using three drugs to control their disease. Thus, GSK expects ample demand for Trelegy Ellipta due to the convenience and intensive treatment that it offers, and this is expected to help GSK retain its lead in respiratory medicine despite falling sales of its older drug Advair.

Mike Aguiar, Chief Executive Officer (CEO) of Innoviva, stated that Trelegy Ellipta providing the convenience of administration of three classes of medicines in a single inhaler is an important advancement in the field of inhaled therapeutics. Trelegy Ellipta comprises all three major classes of combination medication, i.e. ICS/LABA, LAMA/LABA, and now single inhaler triple therapy.

Last Close Stock Review

At the close of trading session on Friday, November 17, 2017, GlaxoSmithKline's stock price slightly declined 0.37% to end the day at $35.06. A total volume of 2.59 million shares were exchanged during the session. The Company's shares are trading at a PE ratio of 27.96 and have a dividend yield of 5.73%. At Friday's closing price, the stock's net capitalization stands at $85.72 billion.

At the closing bell, on Friday, November 17, 2017, Innoviva's stock marginally rose 0.69%, ending the trading session at $13.06. A total volume of 637.05 thousand shares have exchanged hands. The Company's stock price rallied 8.29% in the last three months, 8.11% in the past six months, and 18.08% in the previous twelve months. Moreover, the stock surged 22.06% since the start of the year. The stock is trading at a PE ratio of 16.51 and currently has a market cap of $1.40 billion.

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