Tolebrutinib (tolebrutinib)

2022: Side effects of the drug against multiple sclerosis

In July 2022, the American medical regulator FDA ordered the pharmaceutical company Sanofi to stop testing the drug against multiple sclerosis. The cause was dangerous side effects. Seeing cases of drug-induced liver damage, authorities imposed a partial clinical ban on phase three trials of the drug, further reinforcing doubts about the appropriateness of Sanofi's takeover of Principia Biopharma.

Sanofi struck a deal to buy Principia in 2020 and then brushed off concerns about the limited mid-phase data on tolebrutinib and wider doubts about the effectiveness of the Bruton tyrosine kinase inhibitor (BTK) in autoimmune diseases. In order to make this asset a key part of its attempt to launch research and development after taking over as CEO. In July 2022, the US Department of Health slowed down Sanofi's efforts to bring the molecule to market.

In the drug against multiple sclerosis, the rights to which Sanofi bought for $3.7 billion, found serious side effects

This study affects phase 3 clinical trials of BTK in multiple sclerosis and myasthenia gravis. According to the conditions of the partial clinical ban of the department, the recruitment of participants in American sites is stopped, and dosing is suspended for those subjects who are in the study for less than 60 days. Sanofi may continue to dose the drug to participants who have been in the study for at least 60 days.

Sanofi revised the study's protocols in May 2021 after previously discussing the cases with the FDA. The set of changes included the addition of pre-existing risk factors for hepatic dysfunction to the exclusion criteria. These changes have not yet been reflected in the research lists on the site ClinicalTrials.gov.

According to Fiercebiotech, by early July 2022, outside the United States, the recruitment of participants continues in accordance with revised protocols. Continued research in other parts of the world should mitigate the impact of the partial suspension, given the geographic distribution of research sites due to the fact that American facilities account for 13% and 23% of sites in two phase three clinical trials.^[1]

Notes

Шаблон:Remarks