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GSK's severe asthma therapy Nucala gets EU nod

Becomes the first IL-5 inhibitor to be approved in the EU

GlaxoSmithKline GSK

GlaxoSmithKline's first-in-class interleukin-5 (IL-5) inhibitor Nucala has been approved in the EU as a steroid-sparing therapy for patients with severe asthma.

Nucala (mepolizumab) has been cleared by the European Commission as an add-on treatment for severe refractory eosinophilic asthma in adult patients, and is the first IL-5 inhibitor to be approved in the EU. GSK said it intends to launch the product onto the market "as soon as possible".

Last month, the US FDA gave the go-ahead for Nucala with a slightly broader indication that included its use in severe asthma patients aged over 12, even though its advisory committee had previously recommended that it be approved in adults only and not adolescents. It was launched in the US earlier this week.

People who suffer from severe eosinophilic asthma "are not the typical asthma' patients many people are familiar with", according to Professor Ian Pavord of the University of Oxford, who was involved with the mepolizumab clinical trial programme.

"Despite taking high doses of inhaled medications, they struggle to control their asthma," he added. "They have particular problems with frequent asthma attacks and can require hospitalisation."

By blocking the activity of IL-5 Nucala dampens down the activity of eosinophils, an inflammatory cell known to be important in asthma. In clinical trials the drug was shown to reduce breakthrough asthma attacks when used as a maintenance therapy on top of standard treatment.

The increase control of symptoms meant that patients on Nucala were also able to reduce their use of oral corticosteroids, which can cause profound side effects, especially when used over long periods of time.

The antibody is administered as a 100mg fixed dose subcutaneous injection every four weeks in addition to the patient's normal respiratory medication.

With approval in both the US and Europe GSK has extended its lead over rival IL-5 inhibitor developers, including AstraZeneca whose benralizumab candidate is currently in phase III trials and Teva which is expected to file reslizumab for approval early next year.

The US launch and EU approval are a boost for GSK, which needs Nucala to perform well as its core respiratory franchise - including big-selling asthma and chronic obstructive pulmonary disease (COPD) therapy Seretide/Advair (fluticasone/salmeterol) - continues to face competitive and pricing pressure.

Analysts have estimated that Nucala should see sales in excess of $500m a year, and potentially $1bn-plus at peak.

Article by
Phil Taylor

7th December 2015

From: Sales, Regulatory

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