GlaxoSmithKline’s (GSK) new chronic obstructive pulmonary disease (COPD) has moved closer to EU registration after being recommended for approval by the Committee for Medicinal Products for Human Use (CHMP).
Anoro (umeclidinium bromide and vilanterol) – developed in collaboration with Theravance – has been backed as a once-daily maintenance treatment for adult COPD patients and is on track for full approval by the European Commission the second quarter of this year.
The CHMP also gave a positive opinion for umeclidinium as a single agent therapy for COPD called Incruse.
Anoro is one of the most important products in GSK’s late-stage pipeline and was first approved by the FDA last December, becoming the first once-daily COPD drug incorporating a long-acting muscarinic antagonist (LAMA) and long-acting beta agonist (LABA) to reach the US market. It has also been given the nod in Canada.
Novartis’ rival product Ultibro (glycopyrronium and indacaterol) was the first LAMA/LABA combination to reach the market in Europe, getting the go-ahead from the EMA last September. Both Anoro and Ultibro have been tipped as big-sellers with peak sales expected to reach blockbuster levels.
Citigroup has predicted the new LAMA/LABA products will help the COPD market expand from around $10bn in 2013 to $14bn in 2018. AstraZeneca, Boehringer Ingelheim/Pfizer and Forest Labs/Almirall are also bringing their own LAMA/LABA combinations through development.
Of the two main rivals, GSK has the strongest presence in COPD at the moment thanks to the runaway success of Advair/Seretide (fluticasone and salmeterol), a combination corticosteroid/beta agonist. Advair sales were a whopping £5.27bn ($8.78bn) last year, rising 4 per cent despite the onset of generic competition in some markets outside the US.
Meanwhile, GSK and Theravance’s respiratory collaboration also led to the approval of Relvar/Breo (fluticasone/vilanterol), a direct successor to Advair. The drug was launched in its first markets towards the end of 2013 with initial sales of £8m ($13m) in the quarter.
As of the start of February it had been launched in the US and Canada for COPD, in the UK, Germany and Denmark for COPD and asthma, and for asthma alone in Japan. Both Anoro and Relvar are critical new drugs for GSK as it prepares for competition to Advair, particularly in the US where a potential regulatory pathway for approval of generics was opened up last year.
Meanwhile, GSK and Theravance are looking at combining three drugs – umeclidinium, vilanterol and fluticasone – in a single inhaler device and have indicated they intend to move ahead with a phase III programme. The two companies are also developing a combination of fluticasone with MABA, a bi-functional bronchodilator with both a muscarinic antagonist and beta-2 receptor agonist activity.