GlaxoSmithKline and partner Theravance have filed regulatory applications in the USA and European Union for their combination respiratory treatment which is seen as a successor to the blockbuster Advair/Seretide.
The firms have made submissions for the once-daily fluticasone furoate/vilanterol combination, which was previously known as Relovair. In Europe, a marketing authorisation application has been filed for the drug, with the proposed brandname Relvar and administered by a new dry powder inhaler called Ellipta, for asthma and chronic obstructive pulmonary disease.
As for the USA, the combo will be known as Breo (also using Ellipta) and it has been filed with the Food and Drug Administration for just the COPD indication. For asthma, GSK and Theravance say they are reviewing the strategy for a future US filing.
The drug was previously dubbed 'Super Advair' as it is the follow-up product to GSK's biggest-selling drug Advair (salmeterol/fluticasone) although the data package for the new combo has left many analysts underwhelmed. Advair first-quarter sales were up 2% to £1.25 billion.
The drug, which combines the inhaled corticosteroid (fluticasone) with a LABA (long-acting beta-agonist; vilanterol), is one of several late-stage assets in the GSK respiratory development portfolio, the firm says. The latter includes a combination of the long-acting muscarinic antagonist (LAMA) umeclidinium bromide and vilanterol, the latter as monotherapy and a muscarinic antagonist-beta2 agonist (MABA); all the above are being developed with Theravance.
Tykerb/Herceptin file pulled in USA
Meantime, GSK has withdrawn a supplemental New Drug Application to the FDA for Tykerb (lapatinib) in combination with Roche's Herceptin (trastuzumab) for the treatment of patients with HER2 (ErbB2)-positive metastatic breast cancer who have received prior therapy with the Swiss major's blockbuster.
Rafael Amado, GSK's head of oncology R&D said discussions with the agency "highlighted questions that could not be addressed with the data currently available". The file has therefore been pulled and the firm will wait for results from ongoing studies testing the combo, though GSK noted that regulatory reviews are continuing in Europe and other regions.