LONDON, UK / ACCESSWIRE / July 25, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for GlaxoSmithKline PLC (NYSE: GSK), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/'symbol=GSK. The Company and Innoviva Inc. (NASDAQ: INVA) submitted to the European Medicines Agency (EMA) for the extended use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI), an inhaled corticosteroid (ICS) / long-acting ß2-agonist (LABA) combination, in patients who are already adequately controlled on an ICS/LABA combination on July 21, 2017. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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About Relvar Ellipta
As of now, FF/VI is approved in Europe for the normal treatment of patients aged 12 and above, who have asthma and are not adequately controlled on both ICS and 'as-needed' short-acting ß2-agonist (SABA) and where the use of a combination product (ICS and LABA) is appropriate. The submission, however, would extend its use to those patients who are already adequately controlled on an ICS/LABA combination.
FF/VI does have its own side effects. It has been proved that it should not be used to treat acute asthma symptoms or an acute exacerbation in COPD, for which a short-acting bronchodilator is required. Some common adverse reactions of the drug include a headache, nasopharyngitis, pneumonia, upper respiratory tract infection, bronchitis, influenza, candidiasis of mouth and throat, oropharyngeal pain, sinusitis, pharyngitis, rhinitis, cough, dysphonia, abdominal pain, arthralgia, back pain, fractures, and pyrexia and muscle spasms.
EU Filing based on Non-Inferiority Lung Function Study
The submission is based on data from a non-inferiority lung function study. The study suggested that patients who have well-controlled asthma are able to switch from twice-daily fluticasone propionate/salmeterol, FP/SAL (Seretide Accuhaler) 250/50 to once-daily FF/VI 100/25, without affecting their lung function.
As per the study, no new safety signals were recognized and the adverse event data was consistent with the known safety profile for FF/VI established in patients with asthma. The study design was consistent with European regulatory authorities.
Study Methodology
After a 4-week open-label treatment period with FP/SAL 250/50 twice-daily, patients who had well-controlled asthma were randomized to receive either FF/VI 100/25 once-daily, FP/SAL 250/50 twice-daily, or FP 250 twice-daily in a double-blind, double-dummy manner for 24 weeks at several centers in 12 countries. The main objective of the study was to demonstrate non-inferiority of Relvar Ellipta 100/25 once daily with Seretide Accuhaler 250/50 twice-daily in adult and adolescent subjects 12 years of age and older with persistent bronchial asthma, well-controlled on twice-daily ICS/LABA. The study concluded with the change from baseline in clinic visit evening FEV1 (pre-bronchodilator and pre-dose) at the end of the 24-week treatment period.
In order to prove the non-inferiority of FF/VI versus FP/SAL, the lower limit of the 95% confidence interval for the mean difference in change from baseline for evening FEV1 needed to be greater than the pre defined margin of -100mL. This was done to rule out the possibility that FF/VI was more than -100mL inferior to FP/SAL.
About Asthma
Asthma is a chronic lung disease which inflames and narrows the airways. This ailment affects around 358 million people worldwide. Although there have been medical developments in this field, more than half of patients still experience poor control and symptoms which significantly impact their daily life.
The causes of asthma are still unknown. However, some believe it is a combination of a person's genetic makeup and the environment. Key risk factors include inhaled substances that provoke allergic reactions or irritate the airways.
About GSK
GSK is one of the world's leading research-based pharmaceutical and healthcare companies. It is committed to improving the quality of human life by enabling people to do more, feel better, and live longer.
About Innoviva
Innoviva is focused on bringing compelling new medicines to patients in need by leveraging its significant expertise in the development, commercialization, and financial management of biopharmaceuticals.
Last Close Stock Review
At the closing bell, on Monday, July 24, 2017, GlaxoSmithKline's stock slightly fell 0.98%, ending the trading session at $42.24. A total volume of 2.99 million shares has exchanged hands, which was higher than the 3-month average volume of 2.77 million shares. The Company's stock price rallied 2.72% in the last three months and 8.53% in the past six months. Moreover, the stock surged 9.69% since the start of the year. The stock is trading at a PE ratio of 47.62 and has a dividend yield of 4.62%. The stock currently has a market cap of $103.01 billion.
On Monday, July 24, 2017, the stock closed the trading session at $12.98, marginally down 0.61% from its previous closing price of $13.06. A total volume of 355.67 thousand shares has exchanged hands. Innoviva's stock price surged 1.25% in the last three months, 22.57% in the past six months, and 12.97% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have rallied 21.31%. The stock is trading at a PE ratio of 23.95. At Monday's closing price, the stock's net capitalization stands at $1.43 billion.
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