GSK and Theravance file COPD drug
pharmafile | July 16, 2012 | News story | Research and Development, Sales and Marketing |Â Â EMA, GSK, Relovair, Revlar, Spiriva, TheravanceÂ
GlaxoSmithKline and US biopharma firm Theravance have submitted their investigational chronic obstructive pulmonary disease (COPD) drug to regulators in Europe and the US.
The application to the European Medicines Agency for COPD also asks for the once-daily fluticasone furoate/vilanterol (FF/VI) to be used as a treatment for asthma sufferers.
FF/VI has been known as Relovair in development, but the companies now want it to carry the brand name Relvar in Europe and Breo in the US: in both regions the 100/25mcg dose would be administered by a new dry powder inhaler called Ellipta.
The asthma doses are 100/25mcg and 200/25mcg and GSK and Theravance say they are reviewing their strategy for a future US filing in this indication.
The applications have met a pre-announced timetable from the companies and, if successful, the drug would be competing in COPD with treatments such as Boehringer Ingelheim and Pfizer’s Spiriva.
However, it saw mixed results in late-stage trials: although designed as a follow-up to GSK’s blockbuster Seretide (Advair in the US), the biggest-selling drug in the market, Relovair failed to prove itself superior.
But Advair is approaching the end of its US patent life and, while it is unlikely that the complex drug will face intense generic competition, new treatments for the disease are needed.
COPD is a catch-all term for two conditions – chronic bronchitis and emphysema – usually caused by smoking and it affects an estimated 210 million people worldwide.
It is projected to be the third leading cause of death worldwide by 2020 and remains impossible to cure or even to halt in its progression.
GSK sees this as a potentially fruitful area: its respiratory pipeline includes the investigational LAMA/LABA combination umeclidinium bromide/vilanterol (UMEC/VI), VI on its own, and MABA (GSK961081).
The manufacturer also has investigational medicines FF monotherapy, UMEC monotherapy and anti-IL5 MAb (mepolizumab).
Adam Hill
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