The FDA's Pulmonary-Allergy Drugs Advisory Committee voted 10-3 to recommend approval of Boehringer Ingelheim's mist formulation of its dry-powder inhalable treatment for chronic obstructive pulmonary disease.
The COPD market has its fair share of contenders, but that's not stopping Boehringer Ingelheim from joining the party. The German drugmaker has nabbed FDA approval for its own entrant, which will go up against the likes of Glaxo's aging giant Advair in a market-share showdown. But despite the competition, BI is hoping it can still find its corner.
The FDA approved Boehringer Ingelheim's COPD treatment Striverdi Respimat, a once-a-day inhaler the German drugmaker hopes can contend in a crowded respiratory market.
The blockbuster duo of GlaxoSmithKline and Theravance are pushing a new respiratory combo therapy into late-stage study, pooling the active ingredients from its last two approved COPD treatments to create a once-daily inhaler.
Rivals Novartis and Boehringer Ingelheim are touting positive results for their combination COPD treatments, duking it out with GlaxoSmithKline for dominance of a market that could reach $14 billion by 2018.
Novartis' generic of Advair in Europe is already a thorn in GlaxoSmithKline's side when it comes to sales of the declining blockbuster. Now, it says, another of its lung drugs has turned out positive study data that show its non-inferiority to Glaxo's top seller in COPD, and with its more convenient dosing regimen, it could prompt patients on Advair to make the switch.
European regulatory authorities gave Teva a positive opinion for its DuoResp Spiromax inhalation powder, designed to treat asthma and chronic obstructive pulmonary disease. With the recommendation from the Committee for Medicinal Products for Human Use, Teva hopes to have final approval within a few months.
While it's still unclear how long copycats will take to make a serious dent in GlaxoSmithKline's respiratory franchise once generic competition inevitably erodes sales of the $8.8 billion-selling Advair, Glaxo may soon have a new building block with European regulators' new recommendation for combo med Anoro.
3M Drug Delivery Systems has joined forces with the Delaware outfit Invion to develop inhaled drugs for inflammatory airway diseases.
Massachusetts-based dry-powder specialist Pulmatrix welcomed successful early-stage results for its bronchodilator treatment for chronic obstructive pulmonary disorder, which makes use of its novel lung delivery system iSPERSE.