GSK share price: Pharmco seeks approval for triple respiratory therapy

on Nov 21, 2016
Updated: Oct 21, 2019
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GlaxoSmithKline (LON:GSK) has filed its new experimental triple respiratory treatment for US approval, the blue-chip company has said. The news comes after the FTSE 100 group revealed plans earlier this year to bring forward the submission as it competes with rivals to develop ‘close triple’ therapies which offer a single inhaler for patients with chronic obstructive pulmonary disease (COPD).

GSK’s share price has slipped marginally into the red in London in today’s session, having lost 0.13 percent as of 13:08 GMT. The stock is underperforming the broader market, with the benchmark FTSE 100 index having climbed into positive territory and currently standing 0.38 percent higher at 6,801.53 points. The group’s shares have gained more than 11 percent over the past year, as compared with about a seven-percent rise in the Footsie.

GSK announced in a statement today that it had filed a regulatory submission with the US Food and Drug Administration (FDA) for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol for patients with COPD. The combination therapy, co-developed with San Francisco-based Innoviva, is delivered once daily in GSK’s dry powder inhaler Ellipta.
“This first regulatory submission of our closed triple therapy brings us a step closer to providing a once-daily treatment in a single Ellipta inhaler as an alternative option for those patients who require multiple therapies,” Dave Allen, GSK’s Head of Respiratory R&D, commented in the statement.
The submission comes after the triple therapy met its two goals in a late-stage trial earlier this year, improving lung function as well as health-related quality of life in patients suffering from COPD. GSK noted that a regulatory filing in the EU is planned in the coming weeks and is expected to be followed by submissions in other countries early next year.
As of 13:26 GMT, Monday, 21 November, GlaxoSmithKline plc share price is 1,521.00p.

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