Shire’s prucalopride finally moves ahead in the US

Snippets

Nine long years after its approval in Europe, Shire’s prucalopride is finally approaching the US market. The chronic idiopathic constipation drug has been unanimously backed by an FDA advisory panel and the agency is now odds-on to approve it by the action date of December 21. The panel also voted, again unanimously, that Shire had “adequately addressed” the risk of cardiovascular events which has bedevilled 5-HT4 receptor agonists – the class to which prucalopride belongs – to the extent that Novartis’s Zelnorm was pulled from market in 2007. As a gastrointestinal motility agent prucalopride would offer a new mechanism; other chronic idiopathic constipation therapies such as Linzess, Trulance and Amitiza work by increasing fluid production. Many patients are unsatisfactorily treated with these products, according to Stifel analysts, so prucalopride could find a niche. According to EvaluatePharma’s consensus sales forecasts, however, the drug will trail these competitors out to 2024.

Selected constipation therapies

 

 

Annual indication sales ($m)

Product

Company

2018

2020

2022

2024

Trulance

Synergy Pharmaceuticals

75

269

459

616

Linzess

Allergan

422

487

548

583

Amitiza

Takeda

309

312

179

171

Resolor

Shire

14

48

80

115

 

Total

1,734

2,068

2,270

2,552

Source: EvaluatePharma.

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