GlaxoSmithKline grabs FDA approval for its latest asthma treatment

GlaxoSmithKline's ($GSK) banner respiratory division picked up another FDA approval, securing the agency's blessing for an inhaled asthma treatment as it expands its stable of drugs for airway disorders.

The treatment, to be marketed as Arnuity Ellipta, is a powdered form of the corticosteroid fluticasone furoate, which makes up one half of the recently approved bronchodilator Breo Ellipta. Taken once a day, the drug is designed to serve as a maintenance treatment for asthma sufferers, tamping down flare-ups and serving as a prophylactic therapy.

Arnuity proved itself safe and effective across a slew of studies on more than 3,600 asthma patients GSK said, and the drug's approval marks the company's fourth regulatory victory for a respiratory treatment in a little more than a year.

"The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio," Senior Vice President Darrell Baker said in a statement. "It is the first asthma treatment from our new portfolio to have gained approval in the U.S. and enables us to begin expanding the range of medicines that we offer to physicians and appropriate patients."

Included in that new portfolio is Incruse, a COPD treatment using the long-acting muscarinic antagonist umeclidinium; Breo, which combines Arnuity's powder with the long-acting beta2 agonist vilanterol to treat the same disease; and Anoro, a respiratory treatment that mixes umeclidinium and vilanterol. Each therapy is delivered through GSK's Ellipta inhaler.

And GSK has plans to widen its lead in the respiratory space, teaming up with long-time partner Theravance ($THRX) to study a new treatment that pools the active ingredients in Anoro and Breo to create a triple-threat solution for COPD. The pair plans to enroll 10,000 patients in a Phase III trial to see if the new drug can beat out its parts on their own.

- read the statement