PTC Therapeutics' muscle disorder drug wins conditional EU approval

(Reuters) - PTC Therapeutics Inc said European regulators have given conditional approval to its muscle wasting disorder drug, sending its shares up 4.5 percent in early trading on Monday. The approval is the first in the world for a drug designed to treat the underlying cause of Duchenne muscular dystrophy (DMD) - a genetic disorder that causes muscle degeneration and eventual death in boys. Conditional marketing authorization of a drug allows for the marketing of medicines designed to treat life-threatening diseases that have few or no treatment options, even if comprehensive clinical data is not yet available. As part of the conditional approval, PTC is obliged to complete a confirmatory late-stage trial of the drug, Translarna, and submit additional efficacy and safety data.



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