U.S. pauses new patients on Merck MS drug in blow to shares
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[April 12, 2023]
BERLIN (Reuters) -Merck KGaA said on Wednesday the U.S. Food and
Drug Administration (FDA) had paused the initiation of new patients on
its multiple sclerosis evobrutinib drug, knocking the German drugmaker's
share price.
Merck has been ahead in the race to develop a drug from the class known
as Bruton's tyrosine kinase (BTK) inhibitors to slow the progression of
nerve disease multiple sclerosis. But tolerability of the class has been
a big concern for analysts.
Merck shares were 6.3% lower at 1037 GMT and slid to the bottom of
Germany's blue-chip DAX index on news of the setback.
The FDA's decision, Merck said, was in response to laboratory results
which suggested drug-induced liver injury during phase III studies. The
two cases identified had been asymptomatic and the patients' liver
enzymes had fully normalized after discontinuation of the study
medication.
"Merck is working closely with the FDA to establish the best path
forward for the benefit of patients in current and future trials with
evobrutinib," it said in a statement.
The company must now place on hold the initiation of new evobrutinib
patients and halt studies involving patients who have been taking the
drug for less than 70 days.
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A logo of drugs and chemicals group
Merck KGaA is pictured in Darmstadt, Germany January 28, 2016.
REUTERS/Ralph Orlowski/
The FDA's decision impacts just two
patients. Recruitment for a phase III trial was already complete
with 2,000 participants and an ongoing study is to continue as
planned.
Merck expects to present the first data from that study in the
fourth quarter of 2023.
A trial testing Sanofi's rival candidate tolebrutinib - from the
$3.7 billion takeover of Principia Biopharma in 2020 - was put on
partial hold by the FDA in June 2022 on concerns over harmful
effects on the liver. That meant recruitment of new participants was
stopped.
Others in the development race are remibrutinib from Novartis and
Roche’s fenebrutinib.
(Reporting by Rachel More, Ludwig Burger and Patricia Weiss, Editing
by Friederike Heine, Emelia Sithole-Matarise and Alexander Smith)
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