By Marleen Kaesebier and Patricia Weiss<\/p>\n
ZURICH, April 22 (Reuters) – Swiss drugmaker Roche on Wednesday said it was submitting its experimental multiple \u200csclerosis drug fenebrutinib to global regulators after meeting late-stage trial goals \u200cwhile data released on Wednesday showed seven patients died during studies.<\/p>\n
The company already shared its \u200blate-stage trial results in patients with primary progressive multiple sclerosis (PPMS), but Wednesday’s data provided more details on its efficacy in relapsing multiple sclerosis (RMS).<\/p>\n
Compared with oral drug teriflunomide, which also treats RMS and is made by France’s Sanofi, Roche’s experimental \u200cdrug more than doubles a \u2060patient’s time without relapses, the company’s Chief Medical Officer Levi Garraway said.<\/p>\n
Patient deaths, however, differed starkly. While Sanofi’s drug, \u2060which has been on the market for 13 years, saw one patient die (0.1%) during studies, fenebrutinib had seven deaths (0.9%) during studies and one after that.<\/p>\n
“There are \u200ba couple \u200bof cases where the investigators did \u200bthink the deaths were related \u200cto the study drug and both of those were infections,” Garraway said in an interview, adding that the pattern of the other deaths was unclear.<\/p>\n
None of these were linked to liver-related side effects, Garraway said, adding that severe liver toxicity issues were on par with the competitor’s drug.<\/p>\n
Jefferies analysts in \u200cFebruary voiced scepticism about fenebrutinib being granted \u200bregulatory approval due to liver side effects and \u200bsaid analysts’ peak sales expectations \u200bof around three billion Swiss francs ($3.85 billion) were likely \u200ctoo optimistic.<\/p>\n
Garraway said the company believes \u200bthe overall benefit-risk profile \u200bof the drug to be favourable and if regulatory authorities agree, it expects the drug to be approved. He did not comment \u200bon sales expectations, but \u200csaid the firm does not expect the drug to replace Roche’s \u200bexisting MS drug Ocrevus.<\/p>\n
($1 = 0.7783 Swiss francs)<\/p>\n
(Reporting by Marleen Kaesebier and \u200bPatricia Weiss; Editing by Thomas Derpinghaus)<\/p>\n","protected":false},"excerpt":{"rendered":"By Marleen Kaesebier and Patricia Weiss ZURICH, April 22 (Reuters) – Swiss drugmaker Roche on Wednesday said it…\n","protected":false},"author":2,"featured_media":53869,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[124],"tags":[7997,30320,30060,153,30319,3752,134,276],"class_list":{"0":"post-58125","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-roche","8":"tag-experimental-drug","9":"tag-france39s-sanofi","10":"tag-levi-garraway","11":"tag-multiple-sclerosis","12":"tag-patient-deaths","13":"tag-patients","14":"tag-roche","15":"tag-swiss-francs"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ch\/116492847613132738","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/58125","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/comments?post=58125"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/58125\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/53869"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=58125"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=58125"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=58125"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}