A mixed day for GlaxoSmithKline's respiratory franchise saw the UK major get the thumbs-up from the US Food and Drug Administration for its chronic obstructive pulmonary disease drug Anoro but Danish regulators approved Novartis/Vectura's copy of the blockbuster Advair.
First up, the FDA has approved Anoro, which is a combination of the long-acting muscarinic antagonist (LAMA) umeclidinium bromide and the long-acting beta2 (LABA) agonist vilanterol delivered through the Ellipta inhaler. It has been backed as once-daily, long-term maintenance treatment of airflow obstruction in patients with COPD.
The safety and efficacy of Anoro, which has been developed with Theravance, were evaluated in over 2,400 patients and those treated showed improved lung function compared to placebo. However, the drug carries a boxed warning that LABAs increase the risk of asthma-related death and comes with a medication guide.
The FDA stressed that Anoro is not approved for asthma and should not be used as a rescue therapy to treat sudden breathing problems.
Nevertheless, GSK is delighted and Darrell Baker, head of the firm's respiratory franchise, said it will be an important treatment option for appropriate patients. He noted that it is the first combination product approved in the USA that delivers two once-daily bronchodilators in a single inhaler and "this approval is a significant achievement".
Theravance will make a milestone of $30 million following approval and a further $30 million payment to GSK following launch in the first quarter of 2014. In May, the FDA approved another GSK/Theravance COPD drug called Breo Ellipta, a combination and the corticosteroid fluticasone furoate.
OK for Novartis/Vectura's AirFluSal Forspiro
Putting a bit of a dampener was news coming from Denmark that the regulator there has approved Novartis unit Sandoz' AirFluSal Forspiro (formerly known as VR315), combination of the LABA salmeterol and the inhaled corticosteroid fluticasone, the same combo found in GSK's Advair.
The Danish approval for the combo follows the completion of European decentralised procedures for seven additional countries. Denmark has approved both mid and high-strength dosage forms of AirFluSal Forspiro for the continuous treatment of patients above 12 years of age with persistent asthma or for COPD in the same patient group.
Advair, also sold as Seretide, is GSK's top-seller and had third quarter sales of £1.20 billion. Many companies have been supposedly working on a version of the combo which is off-patent in a number of territories but GSK has previously said that even though copycat versions containing the same active ingredients will be available, the inhaler device used for the drug means that competing products will not be fully substitutable.
Although not directly substitutable for Advair, Sandoz and Vectura have faith in their innovative new inhalation device, which has won design awards. Observers will be keenly analysing the take-up of AirFluSal Forspiro when the seven other EU countries grant approval.