- British drugmaker GlaxoSmithKline plc said Monday it had secured U.S. approval for its three-in-one inhaler for chronic lung disease, strengthening its mainstay respiratory business amid a company-wide refocusing to core therapeutic areas.
- The triple therapy, which will be sold under the brand name Trelegy Ellipta, is one of three key priorities singled out by company CEO Emma Walmsley as near-term catalysts for a company still struggling to find its footing after years of missed opportunities in R&D.
- Falling sales of GSK's flagship Advair treatment have put pressure on the company to deliver new sources of growth, particularly as looming entry of generic copies to the drug threaten to further dent revenues.
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is the first once-daily product for chronic obstructive pulmonary disease that combines three therapies into a single inhaler. The inhaler gives GSK a new treatment option to reach patients who are already taking fixed-dose combinations of two of Trelegy's active ingredients but need additional treatment of airflow obstruction.
"If we just look at how patients are treated today, about a quarter of patients are on triple therapy now, and so we believe that that is a strong base of business to be able to shift to closed triple," said GSK's Eric Dube, who heads the drugmaker's global respiratory franchise, at a July investor event.
Dube highlighted how many patients receiving "open" triple therapy use two different devices to deliver multiple types of medicine, potentially up to three times a day. Trelegy Ellipta — by combining a long-acting muscarinic antagonist, a long-acting beta2-adrenergic agonist and an inhaled corticosteroid — offers a significantly more convenient treatment for that quarter of COPD patients who end up on triple therapy.
Trelegy Ellipta, which GSK said would be "available in the U.S. shortly," beats out rival triple combinations currently in development by AstraZeneca plc and Novartis AG.
GSK's drug is only approved for COPD, not for relief of acute bronchospasm or asthma, although it does have a Phase 3 trial in progress studying the combo in that latter condition.
In asthma, the British company could face stiffer competition as AstraZeneca and Sanofi SA advance development of biologic treatments for the condition. Positive results from AstraZeneca's tezepelumab and Sanofi's Dupixent(dupilumab) suggest the space could see new treatment options in the near future.
Future competition in asthma notwithstanding, approval of Trelegy gives GSK a potential growth driver in respiratory disease ahead of generic competition to its Advair (fluticasone/salmeterol) brand.
GSK dodged two bullets this year, with regulatory setbacks to Mylan NV and U.K.-based Hikma Pharmaceuticals delaying entry of copycat versions to the drug. But the competitive threat remains and could halve sales of Advair once realized.
Partially in response, Walmsley has rolled out plans to overhaul R&D and focus the company's resources behind new launches in respiratory, HIV and oncology. A fast launch of Trelegy would give Walmsley more breathing room to execute on those turnaround plans.