* Nucala is first in new drug class for severe asthma
* EMA weighs verdict on Nucala at Sept. 21-24 meeting
By Ben Hirschler
LONDON, Sept 23 (Reuters) - GlaxoSmithKline may geta green light from European regulators as early as this week fora new biotech medicine to treat severe asthma, boostingprospects for its struggling respiratory business.
A recommendation from the European Medicines Agency (EMA)would confirm the British drugmaker's lead in a race to developan injectable drug for patients with severe asthma who don'trespond well to traditional inhalers.
GSK's Nucala, or mepolizumab, is being assessed by expertsat a four-day meeting that concludes on Thursday, according toan EMA agenda. (http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/2015/09/WC500193944.pdf)
The U.S. Food and Drug Administration is due to give itsdecision on the drug by Nov. 4.
Despite treatment advances in recent decades, asthma isstill not well controlled in a significant minority of patients,creating what analysts believe is a multibillion-dollaropportunity for the new injections.
Rivals in the field include AstraZeneca, Roche, Teva and Sanofi - but Eric Dube,head of GSK's respiratory business, believes his company isaround one year ahead of rivals.
"Clearly there is a first-mover advantage here," he toldReuters. "However, we don't have that much time to establishNucala as the leader in severe asthma."
Significantly, the new drugs offer a more personalisedapproach to asthma care, with patients undergoing so-called"biomarker" blood tests to check if they are likely to respond.
This targeted approach is gaining traction in many medicalfields, most notably cancer, and drugmakers hope it will beattractive to governments and insurers, since it means the drugswill only go to patients who are likely to benefit.
Biotech medicines like Nucala will not be cheap, since theyare made from complex antibodies, though GSK is not giving anyindication on cost before launch.
GSK has been the leader in asthma since launching itsVentolin inhaler in 1969 but its core respiratory business iscurrently suffering, due to declining sales of top-sellerAdvair, while a successor inhaler, Breo, also had a recentsetback.
Nonetheless, Dube believes GSK will maintain itsmarket-leading position in a global respiratory market that isgrowing by a modest 2 percent a year, although the shape of thebusiness will be different in future.
By 2020, GSK expects 90 percent of its respiratory sales tocome from nine products, including Nucala, up from just fourdrugs this year. (Editing by Elaine Hardcastle)