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CHMP backs GSK's asthma antibody and Novartis' heart failure drug

Positive opinions for GSK's IL-5 antibody and Novartis' potential $5bn-a-year brand

GlaxoSmithKline's mepolizumab for severe asthma and Novartis new' heart failure therapy Entresto have been recommended for approval by the Committee for Medicinal Products for Human Use (CHMP).

The panel issued positive opinions for the two drugs during its latest meeting on 21-24 September, setting them on course for formal approval by the European Medicines Agency (EMA) by the end of the year.

For Novartis, the green light for Entresto (valsartan/sacubitril) comes shortly after the product - widely tipped as a future blockbuster - has already been approved in the US and Switzerland. It was the first product to be granted an accelerated review by the EMA.

The recommendation for approval comes on the back of the PARADIGM-HF trial, which was halted early after an interim analysis revealed the combination drug cut cardiovascular deaths by 20% compared to standard therapy based on the ACE inhibitor enalapril, whilst also reducing hospitalisations by 21% and all-cause mortality by 16%.

Pending final approval, the drug will be available for the treatment of adult patients with symptomatic chronic heart failure and reduced ejection fraction (HFrEF), and is likely to replace ACE inhibitors as the 'bedrock treatment' for these patients, according to John McMurray of the University of Glasgow, who was one of the principal investigators in PARADIGM-HF.

Novartis has previously estimated that Entresto could eventually grow into a $5bn-a-year brand.

Meanwhile for GSK the CHMP's backing for mepolizumab makes it the first company to bring an interleukin-5 (IL-5) monoclonal antibody through to this stage of development in Europe. The drug is delivered as a 100mg fixed dose via a subcutaneous injection every four weeks for adults with severe eosinophilic asthma.

The drug is not yet approved anywhere in the world but was recommended for approval by an FDA advisory committee in June and has been filed for approval in Japan. Once EMA approval is granted the drug will be sold in Europe as Nucala.

The positive opinion comes on the back of a phase III development programme in 915 patients who received mepolizumab which showed the drug was effective in controlling asthma symptoms in patients already treated with a battery of drugs, including systemic corticosteroids.

GSK is racing to market alongside other IL-5 inhibitor developers including Teva, which has filed its Cinquil (reslizumab) candidate, and AstraZeneca which is due to submit benralizumab for approval next year.

Analysts have suggested the IL-5 inhibitor class as a whole could achieve sales of $7.5bn a year at peak.

Article by
Phil Taylor

25th September 2015

From: Regulatory



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