
PTC Therapeutics to cut jobs after FDA rejects Duchenne drug
pharmafile | March 24, 2016 | News story | Manufacturing and Production |Â Â Duchenne Muscular Dystrophy, PTC TherapeuticsÂ
PTC Therapeutics has announced plans to reduce its operating expenses that will see it cut almost a fifth of its workforce.
The news comes just weeks after the FDA rejected its drug Translarna (ataluren) for the treatment of the rare muscle-wasting condition Duchenne Muscular Dystrophy (DMD). The US regulator said there was insufficient evidence that the drug was efficacious in treating the condition, after it failed to meet primary endpoints in two late-stage trials.
The 18% cuts to the workforce are set to hit the US workforce hardest, and will begin immediately, with the company expected to have to pay out some $2.5 million in compensation to the affected staff.
The FDA’s decision, which sent PTC stocks plummeting, could also impact on the upcoming judgement from European regulator EMA. While EMA gave Translarna an accelerated approval in 2014, the approval is reviewed annually and is likely to be revoked on the failure of the Phase III trials.
The failure of PTC’s drug, along with that of BioMarin in January, leaves sufferers of DMD without any approved medicines to turn to treat their condition.
Joel Levy
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