By Marleen Kaesebier and Patricia Weiss
ZURICH, April 22 (Reuters) – Swiss drugmaker Roche on Wednesday said it was submitting its experimental multiple sclerosis drug fenebrutinib to global regulators after meeting late-stage trial goals while data released on Wednesday showed seven patients died during studies.
The company already shared its late-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).
Compared with oral drug teriflunomide, which also treats RMS and is made by France’s Sanofi, Roche’s experimental drug more than doubles a patient’s time without relapses, the company’s Chief Medical Officer Levi Garraway said.
Patient deaths, however, differed starkly. While Sanofi’s drug, which 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.
“There are a couple of cases where the investigators did think the deaths were related to the study drug and both of those were infections,” Garraway said in an interview, adding that the pattern of the other deaths was unclear.
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.
UBS analysts said that while the two deaths may pose a regulatory risk, the benefit-to-risk profile of fenebrutinib otherwise appeared to be reasonable.
Scepticism about potential regulatory setbacks around the drug’s liver side effects had made Jefferies analysts say in February that analysts’ peak sales expectations of around three billion Swiss francs ($3.85 billion) were likely too optimistic.
Garraway said the company believes the overall benefit-risk profile of the drug to be favourable and if regulatory authorities agree, it expects the drug to be approved. He did not comment on sales expectations, but said the firm does not expect the drug to replace Roche’s existing MS drug Ocrevus.
($1 = 0.7783 Swiss francs)
(Reporting by Marleen Kaesebier and Patricia Weiss; Editing by Thomas Derpinghaus and Louise Heavens)
