Glaxo’s asthma treatment under review

According to Reuters, GlaxoSmithKline Plc’s new respiratory treatment for chronic breathing problems is being reviewed to ensure the safety of the drug over long term use to treat asthma patients.

According to the US Food and Drugs Administration (FDA), they are conducting review of the treatment and are also carrying out the discussion on approval of the combination treatment, Breo Ellipta.

The agency has already approved the inhaled drug combination of vilanterol and corticosteroid for treatment of chronic obstructive pulmonary disease, which is a breathing disability. It becomes severe over time and generally smokers are only affected by it.

The FDA seeks recommendations of its outside advisors on whether adults and children with asthma could take Breo. According to a memo by FDA’s Office of Pediatric Therapeutics, it does not seem that the effect of Breo is much better than steroids alone for patients ages 12 to 17 and individual of this age group were more affected than the older ones.

According to the memo, “In view of the safety concerns, the lack of definitive efficacy findings in the 12-17 year old age group would suggest that the committee consider very carefully whether Breo Ellipta has a positive benefit/risk profile in this age group”.

The FDA is also looking forward to the panel’s opinion on whether a large safety trial for analyzing serious asthma outcomes could be conducted prior to approval or after that. Two long-term studies are also being conducted by Glaxo on its drug Advair, which was approved in 2000.

According to the National Institutes of Health, wheezing, shortness of breath and coughing could be caused by asthma, and 25 million people in the US, together with 7 million children, are affected by the disease.