Relvar Ellipta: Over the past few days, research-based pharmaceutical GlaxoSmithKline plc (ADR) (NYSE:GSK) and biopharmaceutical company Theravance Inc (NASDAQ:THRX)’s Relvar Ellipta has been in the news. This is the proposed proprietary name for FF/VI 100/25 – 200/25 mcg, a combination of the inhaled corticosteroid (ICS) fluticasone furoate “FF” and the long acting bronchodilator (LABA) vilanterol “VI” (FF/VI). Both dosages are administered once-daily using the Ellipta, a new dry powder inhaler (DPI), making it the first once-daily, inhaled drug of its kind.
Recently, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of their candidate Relvar Ellipta in the EU. By the end of the year a final decision is expected to be made.
The CHMP recommended the approval of Relvar Ellipta only for the regular treatment of asthma in adults and adolescents –aged above 12 years. This treatment is only recommended in cases where a combination therapy is appropriate. For patients who suffer a asthma that is not sufficiently controlled with inhaled corticosteroids and short-acting inhaled beta 2-agonists the drug has been also recommended. Also, the CHMP backed the drug for the symptomatic treatment of adults suffering from chronic obstructive pulmonary disease (COPD) –term referring to chronic bronchitis and emphysema.
A day after the drug received its recommendation from the EU, Relvar Ellipta received approval also by the Japanese Ministry of Health, Labor and Welfare, for the treatment of bronchial asthma. Here it has only been approved for cases where the parallel use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required. The drug has not been approved to treat COPD. This is contrary to the status the drug possesses in the US, where it can be used to treat COPD –the third most common cause of dead- and not asthma. Subsequent to Japan’s decision, Theravance will make a milestone payment of $10 million to GlaxoSmithKline, as established on their collaboration agreement.
Last May, Theravance’s pipeline programs in collaboration with GlaxoSmithKline already received the approval of another drug, Brea Ellipta, a long term maintenance therapy of airflow obstruction and for patients suffering COPD, in the US and Canada. Although Relvar Ellipta has not been licensed or approved anywhere outside Japan for asthma treatment, it may be likely to be.
Disclosure: Pamela Gaviño holds no position in any stocks mentioned