Reuters Health Medical News
August 1, 2017
There were more deaths in patients taking Johnson and Johnson’s experimental rheumatoid arthritis drug sirukumab than among those taking a placebo, staff reviewers for the U.S. Food and Drug Administration (FDA) said in a report published Monday.
The report comes two days before an outside committee of advisors meets to discuss the drug and recommend whether it should be approved. The FDA is not obliged to follow the advice of its advisors but typically does so.
The most common causes of death were major heart problems, infection and malignancies.
Other potential safety issues related to immune system suppression were similar to other products in the class, but the trend of increased overall mortality “seems unique for the sirukumab program,” the report said. It was published on the FDA’s website.
Johnson and Johnson was originally developing the drug, which would be known as Plivensia if approved, with GlaxoSmithKline Plc (GSK). GSK recently said it would end the program and return all rights to Johnson and Johnson. GSK had rights to the drug in North, Central and South America.
Sirukumab is a human monoclonal antibody that blocks interleukin 6 (IL-6), which can contribute to the inflammation associated with rheumatoid arthritis, an autoimmune disorder that affects more than 1.3 million Americans.
Sirukumab is designed for patients who have failed or cannot tolerate one or more disease modifying drug such as methotrexate.
Sirukumab would compete with Roche Holding AG’s IL-6 inhibitor Actemra (tocilizumab) and a recently approved IL-6 therapy, Kevzara (sarilumab) made by Sanofi SA and Regeneron Pharmaceuticals Inc.
Analysts on average forecast global sales of Kevzara to reach about $667 million by 2020, according to Thomson Reuters data. They expect sales of sirukumab, if approved, to be about $450 million over the same period.
Neither Kevzara nor sirukumab are sufficiently different from Actemra to gain a great deal of traction in the market, said Damien Conover, an analyst with Morningstar.
“I don’t think they are really going to move the needle for any of these large companies,” he said.
Original headline: J&J arthritis drug sirukumab raises safety concerns
Copyright 2017 Reuters Health. All Rights Reserved.
Quality News Today is an ASQ member benefit offering quality related news
from around the world every business day.