England's cost watchdogs hand Amgen's Kyprolis its latest setback


Amgen’s Kyprolis is in the middle of a multiple myeloma battle that’s only growing more and more heated. And a roadblock from England’s cost-effectiveness gatekeepers isn’t going to help it get ahead.

Wednesday, the National Institute for Health and Care Excellence (NICE) shot down the med in combination with dexamethasone and Celgene’s Revlimid or with dexamethasone alone as a treatment for myeloma patients who have tried at least one prior therapy.

The reason? Long-term survival uncertainties that made its cost-effectiveness status hard to determine, NICE said in a draft guidance. Kyprolis didn’t meet its 24-month extension mark for end-of-life treatments, either.


Survey: The Critical Role of Innovation in Launching Successful OTC Products

This research aims to understand the importance of product innovation and dose forms in driving new product design and development, consumer engagement and purchase interest for Over-the-Counter medicines. The first 50 qualified respondents will receive a $5 Amazon gift card. Take the survey now.

The decision is just another downer for Amgen, which has been struggling with Kyprolis since it shelled out $10 billion in 2013 for maker Onyx. The drug has repeatedly failed to live up to analysts’ expectations, most recently coming up $9 million short in Q3.

And with a spate of myeloma approvals late last year, it’s under more pressure than ever to perform. Drugmakers including Johnson & Johnson, which markets Darzalex, are trying to slide their meds into earlier lines of therapy, where larger patient pools and longer treatment durations will help them pad their top lines and give Kyprolis a run for its money.

To make matters worse, it doesn’t look like Kyprolis will be enjoying the sun in the most lucrative front-line setting anytime soon. In late September, it flunked its first Phase III study in newly diagnosed patients.


Suggested Articles

Perrigo is treading water in its specialty drugs reinvention plan. Could a merger with another struggling drugmaker—à la Pfizer and Mylan—be the cure?

AveXis' ex-CSO is "prepared to assert his rights and defend his conduct accordingly," a statement from a lawyer who recently represented Elon…

Hikma says it has picked up some pipeline products and nasal and sublingual spray equipment from Insys Therapeutics' bankruptcy.