Advisors to the European Medicines Agency have voted in favour of approving GlaxoSmithKline/Theravance’s Relvar Ellipta for both asthma and chronic obstructive pulmonary disease.
The EMA’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorisation for Relvar Ellipta, a combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2 agonist (LABA) vilanterol, delivered through the Ellipta inhaler. The drug was approved in the USA in May (but only for COPD) where it will be sold as Breo Ellipta.
As part of its assessment, the EMA reviewed results of 11 clinical studies in 7,851 patients with COPD and 16 trials in 9,326 asthma patients with asthma. A final decision by the European Commission is expected during the fourth quarter.
Patrick Vallance, GSK’s president of pharmaceuticals R&D, noted that the company has been developing these molecules as a potential new combination treatment for over ten years. He added that “what is particularly exciting is that we have achieved the first of what we hope in the future could be many positive regulatory outcomes supporting the potential use of [Relvar] in appropriate patients with asthma”.
The recommendation is yet more good news for GlaxoSmithKline and Theravance as it comes just over a week after advisors to the US Food and Drug Administration recommended approval of another COPD drug Anoro Ellipta, which combines the long-acting muscarinic antagonist (LAMA) umeclidinium bromide with vilanterol.
GSK anthrax pact with US govt
Meantime, GSK has inked a new four-year contract worth $196 million to supply the US Department of Health and Human Services with 60,000 doses of its inhalation anthrax treatment raxibacumab.
Raxibacumab was approved by the FDA in December 2012 for the treatment of patients with inhalation anthrax due to Bacillus anthracis in combination with appropriate antibacterials and for prophylaxis of inhalation anthrax when alternative therapies are not available or appropriate. GSK noted that anthrax is one of the most likely agents to be used in a bioterrorist attack as “its spores are easily found in nature and can be produced in a lab. It can be released into the environment quietly and remain there for a long time”.
Earlier this year, GSK and the US government entered into a separate agreement for up to five years to develop drugs to fight antibiotic resistance and bioterrorism.
Raxibacumab is a monoclonal anti-toxin which was developed by Human Genome Sciences. GSK acquired the company in July 2012.
