Sanofi’s Dupixent wins US approval for bigger use

Sanofi's regulatory filing for EoE is under review by the European Medicines Agency (EMA)

Sanofi won expanded US approval for its Dupixent injection to treat an allergic inflammation of the oesophagus, the Food and Drug Administration (FDA) said last week.

There are more than 160,000 patients in the US living with Eosinophilic Esophagitis (EoE), according to Sanofi.

Sanofi’s regulatory filing for EoE is under review by the European Medicines Agency (EMA), the company said, adding that submissions to regulatory authorities in additional countries are planned by the end of 2022.

The chronic condition typically requires repeated treatments such as corticosterioids and diet change to ease the symptoms and Dupixent is the first treatment that targets the underlying cause.

Anti-inflammation drug Dupixent, jointly developed with Regeneron, is already approved for a range of other uses including atopic dermatitis, also known as eczema and severe asthma.

Sanofi said in March it expected peak annual sales of more than 13 billion euros ($13.77 billion) for the drug, up from a previous target of over 10 billion euros.

That excluded the potential use in Chronic Obstructive Pulmonary Disease (COPD), sometimes called smoker’s lung, where trial results are expected next year.

Dupixent, with 2021 sales of 5.25 billion euros, accounted for 13.9 per cent of group revenue.

Sanofi’s first-quarter adjusted earnings gained 16.2 per cent on sales growth of the blockbuster drug and a rebound in demand for prescription-free drugs.

Revenue from Dupixent jumped over 45 per cent to 1.61 billion euros in the quarter, beating an analyst consensus, on prescriptions in dermatitis, asthma and certain nasal infections.

Edited by EP News Bureau

DupixentSanofiUS FDA approval
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