The drug was approved under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and address an unmet medical need, based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
Tag Archive for: liver damage
The company’s CEO said its experimental multiple sclerosis drug can be a “blockbuster”, an industry term for annual sales that exceed $1 billion, even after concerns emerged that the drug may cause liver damage.
With Intercept’s failure to emerge as the non-alcoholic steatohepatitis market leader, Madrigal Pharmaceuticals is seeking to take leadership of the space fueled by a half-a-billion-dollar public offering.
The company stated that its multiple sclerosis drug candidate, part of a class of compounds that has been linked to cases of liver damage, reduced brain lesions in a mid-stage trial and that no new safety concerns emerged.