Sanofi MS drug hits two setbacks
Summary
Sanofi’s experimental drug, tolebrutinib, has failed to meet its main goal in a late-stage trial for primary progressive multiple sclerosis (MS). The company has also announced that an approval decision for the drug in non-relapsing secondary progressive MS will be delayed. However, Sanofi remains confident in the drug’s risk-benefit profile and has submitted an expanded access program for eligible patients.
Access impact
The negative results from the PERSEUS trial mean that Sanofi will not seek approval for tolebrutinib in primary progressive MS. This will have implications for the drug’s potential pricing and reimbursement in this indication. The delay in the approval decision for non-relapsing secondary progressive MS also means that the drug may not be available for patients who could benefit from it. These setbacks may also impact the company’s financials and investor confidence.
Top-3 domain lens
Clinical Effectiveness
The PERSEUS trial showed that tolebrutinib did not meet its main goal of delaying disabilities in primary progressive MS patients. This calls into question the drug’s effectiveness in this indication.
Safety and Tolerability
BTK inhibitors, such as tolebrutinib, have shown potential for liver injury. This has led to partial clinical holds on similar drugs in the past and may raise concerns about the safety of tolebrutinib for potential patients and payers.
Evidence Quality and Robustness
Sanofi’s announcement of an expanded access program suggests that they are confident in the drug’s risk-benefit profile. However, the delay in the approval decision for non-relapsing secondary progressive MS raises questions about the quality and robustness of the data supporting the drug’s effectiveness in this indication.
Hashtags
#MarketAccessRiskAssessment #Pricing #Reimbursement #MarketAccess #MARArating #Company #Drug #RegulatoryAgency
CTA
Explore 350+ independent assessments: https://mararating.com/mara-ratings-list
Source
source: https://www.biopharmadive.com/news/sanofi-primary-progressive-ms-tolebrutinib-fda-delay/807865/