GSK’s Breo Gets Positive Review from FDA Panel

The safety of a new drug developed by GlaxoSmithKline and Theravance is ‘generally consistent’ with that of other combination drugs used in treating chronic obstructive pulmonary disease (COPD), a FDA panel has said. The FDA's pulmonary-allergy advisory committee will be meeting next week to review the drug, known as Breo Ellipta. The drug is being seen as a potential successor to GSK’s Advair and has been designed to be taken once every day, which the makers hope will help patients to remember to use the COPD medicine.

Breo is made up of fluticasone furoate, which helps reduce inflammation, corticosteroid and a long-acting beta-agonist called vilanterol. The drug will be inhaled with palm-sized device called Ellipta. While the initial review by the FDA is favorable, the experts had mixed opinions about the drug's efficacy.

Analysts said that the positive review would have come as a relief for the makers. “In addition to strong positive implications for the upcoming panel, we believe the briefing document essentially eliminates the worst-case scenario that dose selection of vilanterol is questioned or if there is a safety surprise which could negatively affect GSK's other filings such as Anoro”, Leerink Swann analyst, Howard Liang said.



Source-Medindia