GSK, Theravance Report Positive Results For FF/VI In Late Stage Asthma Study

(RTTNews) - British drug giant GlaxoSmithKline Plc (GSK, GSK.L) and biopharmaceutical company Theravance, Inc. (THRX) announced Friday that their combination drug met its primary efficacy end point of improving lung function in adult asthma patients in the U.S. in a late-stage trial.

The drug is a combination of inhaled corticosteroid fluticasone furoate (FF) and the long acting bronchodilator vilanterol (VI).

Dave Allen, Head, Respiratory Therapy Area Unit, R&D said, "We are pleased to see the results delivered by FF/VI in the treatment of asthma. We have undertaken a large and comprehensive clinical programme providing data on the efficacy and safety profile for FF/VI in asthma. With these additional data we will consider our next steps in relation to an asthma filing in the US."

The late-stage double-blind, parallel group, multi-center study was conducted over a period of 12 weeks to assess the efficacy and safety of FF/VI 200/25 mcg inhalation powder, FF/VI 100/25 mcg inhalation powder and FF 100 mcg inhalation powder.

The study evaluated 990 patients with moderate to severe persistent asthma. Patients were randomized to one of the three treatments taken once-daily in the evening.

The administration of FF/VI 100/25 mcg combination demonstrated a statistically significant improvement in lung function in adult asthma patients compared to FF 100 mcg only, while FF/VI 200/25 mcg showed an additional improvement compared to FF/VI 100/25 mcg. The drug is administered via a dry powder inhaler called Ellipta.

Meanwhile, the companies revealed that the most common reported side effects across all treatment arms included headache, nasopharyngitis, upper respiratory tract infection and influenza.

The combination drug is already approved by FDA in the U.S. in May 2013 as Breo Ellipta, which is indicated as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease or COPD, and also for the reduction of COPD exacerbation's in patients with a history of exacerbation's.

However, the combination drug is not an FDA-approved treatment for asthma in the U.S., but the positive late-stage study results are designed to support a potential filing.

Meanwhile, the combination drug was approved by Health Canada in July 2013 for the treatment of COPD, but not for asthma. However, the drug, as Relvar Ellipta, has already received approval in Japan in September 2013, in Mexico in October 2013 and in the European Union on November 18 for the treatment of COPD and asthma.

"There is an ongoing unmet medical need among patients with asthma. This is an important outcome for FF/VI and we will continue working with GSK to determine how we can make this potential treatment available to appropriate patients who could benefit from a new asthma medicine," Theravance CEO Rick Winningham said in a statement.

In Friday's regular trading session, GSK is currently trading at $52.56, up $0.34 or 0.65% on a volume of 0.13 million shares, and THRX is trading at $36.75, up $1.19 or 3.38% on a volume of 0.24 million shares.