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GSK’s new asthma biologic gains FDA panel backing

British firm looking to help shore up its ageing respiratory portfolio 

GSK - logo on building

An expert FDA panel has backed GlaxoSmithKline's new asthma drug mepolizumab as the company seeks to grow its respiratory drug offering. 

The treatment was backed unanimously (14-0) as an add-on maintenance treatment for adults with severe asthma with eosinophilic inflammation - a form of the disease that is particularly virulent and often resists treatment even with high-dose inhaled steroids and bronchodilators. Up to a third of all asthma patients are thought to have the eosinophilic form of the disease.

Mepolizumab works as an anti IL-5 monoclonal antibody and is delivered as a 100mg fixed dose via a subcutaneous injection every four weeks for patients with severe asthma. 

The FDA Committee also voted that the efficacy data provided substantial evidence of a clinically meaningful benefit in this population (14 yes, 0 no) and safety in adults with severe asthma had been adequately demonstrated (13 yes, one no).

This decision is not binding and the FDA can still decide to not approve the drug, although this is a rare occurrence. The regulator is set to make a decision on the treatment by early November. 

The Committee did however vote against approval of mepolizumab for use in adolescents 12-17 years of age with severe asthma (four yes, 10 no), recommending that further data are needed in this sub-population where there is a high unmet need.

If approved, mepolizumab would become the second biologic therapy for asthma after Novartis' immunoglobulin E (IgE) inhibitor Xolair (omalizumab), which brought in sales of $613m as an allergic asthma therapy last year and was also recently approved for severe hives.

Patrick Vallance, President, Pharmaceuticals R&D, said: “Our clinical development programme has demonstrated the potential of mepolizumab as a targeted treatment for difficult to treat adults with severe asthma, many of whom have been struggling to live with their condition for many years. 

“These are patients who currently have very few treatment options and our belief in this medicine as a new treatment option has today been reinforced by the Advisory Committee's decision. GSK will continue to work closely with the FDA to complete the review of the BLA for mepolizumab.”

Mepolizumab is also vying with other new drug candidates in late-stage trials for severe asthma, notably AstraZeneca's benralizumab and Teva's Cinquil (reslizumab), both IL-5 inhibitors, as well as Regeneron/Sanofi's IL-4 and IL-13 blocker dupilumab. 

Analysts at Cazenove have previously predicted modest sales for mepolizumab of around £200m ($332m) at peak.

GSK originally developed mepolizumab as a treatment for a rare and sometimes fatal condition called hypereosinophilic syndrome (HES), but withdrew its marketing application for this indication in 2009 in EU after a regulatory request for additional data on its clinical benefits.

The antibody is being investigated in chronic obstructive pulmonary disease (COPD) and a form of vasculitis known as eosinophilic granulomatosis with polyangiitis (formerly known as Churg-Strauss syndrome).

Weakening sales

GSK has suffered a major down turn in sales for the past two years with weakening sales of its respiratory brand - and notable lower sales of its biggest earner Seretide/Advair - predominately to blame. 

The firm recently sold off its cancer drug portfolio to Swiss rival Novartis in order to focus more heavily on vaccines and OTC consumer health products, as well as drugs for asthma and COPD. 

These are all fairly slow and steady growth drivers, however, and Seretide (which made £4.2bn in sales last year) is coming under major pricing pressure as other respiratory drugs gain global market share from this once dominant product. 

Seretide has also seen generic competition in the UK after Mylan launched its copycat version this week, meaning sales will likely be decimated in the region. 

Article by
Ben Adams

15th June 2015

From: Sales



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