GlaxoSmithKline is fighting off a long lineup of respiratory competitors, but it just got a lot closer to potentially coming at them with a triple combo med.
Last week, the pharma giant announced that after talks with the FDA, it had bumped up its plans to file a new drug application for its once-daily ICS/LAMA/LABA combo for COPD patients. Instead of submitting its materials to the agency in the first half of 2018, it now expects to submit them by the end of this year.
Glaxo, of course, already has both ICS/LABA meds--Advair and Breo--and a LAMA/LABA in Anoro. But a triple-combo will add another tool to a COPD arsenal that it’s doing its best to build up.
"What's coming together for us is … the concept of the platform--everything in the Ellipta device, the strong portfolio, the proposition that GSK can offer, when you can go” from a med for severe asthma on one end of the spectrum down to a treatment for less serious forms of the disease, Deborah Waterhouse, GSK's SVP of primary care, told FiercePharmaMarketing last year.
And if Glaxo can win an approval for the combo next year, it won’t be a bad time to get some backup in the COPD department. Generics makers are preparing to enter the market with their own version of GSK behemoth Advair, and while payer pressure has already forced prices on the drug way down in the U.S., copycats are confident that there’s still “quite a bit of room” for generics to take prices even lower, according to Mylan President Rajiv Malik.
“The price is still pretty attractive” to bring knockoffs in, he recently told Reuters.
Then, there’s the threat from new branded meds and combos; AstraZeneca, Boehringer Ingelheim and Novartis have all been doing their best lately to steal market share by taking that route.
In triple-combo-land, though, GSK won’t be so susceptible, with at least one of its rivals not planning to touch that territory.
"We are not ... developing a triple combination for the time being," BI Chairman Andreas Barner told EvaluatePharma last year.
- read GSK's release
Special Reports: The top 15 companies by 2014 revenue - GlaxoSmithKline | The 10 best-selling drugs of 2013 - Advair/Seretide
Wannabe generic Advair makers Mylan, Vectura aim for 'rational' drug pricing
GSK finally has Breo where it wants it--just in time for Advair copies
GSK shoots for diabetes-esque platform approach with new respiratory med in hand
Novartis hopes Seretide-topping data can push docs toward Ultibro
Boehringer faces uphill battle for Stiolto, thanks to payer arm-twisting