Sales Forecast of FDA’s 2017 New Drug Approvals
2017 was a landmark year for the pharmaceutical industries in the US and Europe, with a sharp increase in the number of new molecular entities (NMEs) being approved in both the geographies.
The US Food and Drug Administration (USFDA) approved 46 NMEs in 2017, a strong bounce back from only 22 NMEs approved in 2016.
The 46 approvals by the USFDA’s Center for Drug Evaluation and Research (CDER) is the second highest total since 1996 when 53 NMEs were approved.
In Europe, the European Medicines Agency (EMA) approved 35 drugs with a new active substance, up from 27 in 2016. We also identified eight drugs that got approved in Europe before winning the USFDA nod.
The American stars of 2017, by sales revenue
Of all the drugs approved by the USFDA, the highest expectations are from Regeneron and Sanofi’s first-in-class monoclonal antibody (mAb) — dupilumab. The (IL)-4 receptor subunit-α antagonist has shown benefits in various kinds of inflammatory and allergic diseases.
While the USFDA approved the drug for atopic dermatitis, it is also being developed for asthma, chronic obstructive pulmonary disease (COPD) and other indications.
Evaluate Pharma analysts estimate the sales of dupilumab at US$ 4,938 million by 2022.