Long road ends in green light for long-acting ADHD therapy
Shares in Ireland-headquartered Shire (LSE: SHP) are up more than 2% in London, on news that the rare disease specialist has finally received US Food and Drug Administration approval for its long-acting attention deficit hyperactivity disorder (ADHD) therapy.
The company, which originally filed for FDA approval in 2006, received some pushback from the regulator, including a demand for additional clinical studies.
Shire was at last given the nod based on data from 16 clinical trials evaluating the drug in more than 1,600 subjects, including adolescents and adults.
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