Homing in on a narrower indication appears to have paid off for Amgen, at least in terms of getting its osteoporosis project Evenity past the US FDA. Whether the company will be able to recoup its investment is another matter. Yesterday’s 18-1 advisory committee vote in favour of Evenity, which contains the active ingredient romosozumab, came despite fears of cardiovascular side-effects. Still, the panel highlighted a need for post-marketing follow-up – whether this means another trial is unclear. And Evenity’s potential market is not what it used to be: Amgen originally filed the project for osteoporosis in postmenopausal women, but after a complete response letter in July it narrowed this down to postmenopausal women at a high risk of fracture. Since the CRL analyst forecasts have come down dramatically, EvaluatePharma sellside consensus shows. And any questions over whether Evenity will be profitable are complicated by the fact that Amgen will have to share the proceeds with a partner, UCB. Meanwhile, Radius Health guides that its rival subcutaneous product Tymlos, which was approved in April 2017, will book US sales of $155-175m this year.
|Evenity's changing forecasts|
|Annual sales ($m)|
|Launch year||Year 1||Year 2||Year 3||Year 4||Year 5|
|Forecasts before July 2017 CRL||37||154||304||425||572||698|