Amgen/UCB’s osteoporosis drug hit by cardio risk

Amgen and UCB have suffered a setback to their osteoporosis drug, romosozumab, after first phase 3 trial results revealed a heart safety signal.

Evenity, as it will be branded if approved, is under review with the FDA, which had been due to make a decision on the drug in July.

But the findings from the ARCH study will have to be submitted to the regulator, meaning a regulatory decision is likely to be delayed until next year.

The news sent UCB’s share price down by more than 13.5%, such is the importance of romosozumab, which has been forecast to produce peak sales as high as $6.6 billion.

Amgen’s share price also ticked down following the announcement, while shares in Radius Health jumped as investors noted that its already-approved Tymlosa could have more time on the market without a competitor.

In the ARCH study, 4,093 women received either a subcutaneous injection of romosozumab monthly for 12 months, or weekly alendronate for 12 months, followed by a  period of alendronate therapy lasting at least 12 months.

The data that so concerned investors showed the rate of cardiovascular serious adverse events at 12 months was 2.5% in a romosozumab arm compared to 1.9% in an alendronate arm.

There were no such cardiovascular issues in the 7,180-patient placebo-controlled FRAME study, which forms the basis of the FDA filing.

On the efficacy side there were no further worries in the ARCH study, meeting both primary endpoints of incidence of new spine fractures, reducing risk by 50% through 24 months compared with alendronate.

Those in the romosozumab arm had a 27% reduction in risk of clinical fractures (non-vertebral and clinical vertebral fracture) compared with alendronate, meeting the study’s other primary endpoint.

The study also met a secondary endpoint of non-vertebral fractures, reducing risk by 19%.

Romosozumab is an investigational bone-forming agent that rapidly increases bone formation and reduces bone resorption simultaneously, increases bone mineral density and reduces the risk of fracture.

Sean Harper, executive vice president of R&D at Amgen, said: “The efficacy results from this study comparing romosozumab to an active control are robust. At the same time, the newly observed cardiovascular safety signal will have to be assessed as part of the overall benefit-risk profile for romosozumab.”

Preparation for an EU filing will continue and regulators and Japan and Canada are reviewing dossiers based on the FRAME study.

Epogen biosimilar

In a second setback, a cheaper competitor to Amgen’s key kidney disease drug Epogen (epoetin alfa) moved closer to market, after FDA staffers gave it a glowing review ahead of a meeting of its advisers.

Although the panel’s decision is not binding, the FDA is likely to follow its advice.

Manufactured by Pfizer’s Hospira generics and biosimilars subsidiary, the FDA rejected Epoetin Hospira in October 2015, but following a re-filing the FDA reviewers gave the biosimilar a clean bill of health.

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