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The CEO of Germany’s Merck KGaA said the company’s experimental multiple sclerosis drug can be a “blockbuster,” an industry term for annual sales that exceed $1 billion, even after concerns emerged that it may cause liver damage.

Merck, seen as leading the race to win approval for a more targeted type of MS drug, said in April that U.S. regulators had paused enrolment of new patients into a trial testing the drug, evobrutinib, knocking the German drugmaker’s share price.

At the time, the company said the U.S. Food and Drug Administration had cited laboratory results suggesting drug-induced liver injury, but the two affected patients had no symptoms and did not require any medical intervention.

“We are very confident on the ability to reach blockbuster status. We are first in class,” CEO Belen Garijo told Reuters.

“The readout of our Phase 3 study is going to happen in December,” she added of the pivotal study in the clinical trials process.

Garijo expressed confidence that regulators can be convinced of the drug’s favorable benefit-risk profile.

The company, which is holding a capital markets day at its Darmstadt headquarters on Thursday, had previously guided for initial results from the trial, typically the final stage before seeking approval, would be available by the end of the year.

Rivals are also developing medicines in the class of compounds known as BTK inhibitors, designed to selectively block the cells that drive the harmful autoimmune reaction behind MS.

Sanofi had run into similar problems with its drug candidate. Novartis, also in the race, said in April that no signs of liver damage had been seen in trials testing its anti-inflammatory drug candidate remibrutinib so far.

Roche said in May that its BTK inhibitor against MS, reduced brain lesions associated with the disease in a mid-stage trial and that no new safety concerns had emerged. 

© 2023 Thomson/Reuters. All rights reserved.

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