AbbVie’s Parkinson’s disease therapy gets a No from FDA
AbbVie Inc has announced that the US Food and Drug Administration (FDA) has rejected the company’s Parkinson’s disease therapy for adults, ABBV-951, and has requested additional information on the device used to administer the treatment. ABBV-951 is a subcutaneous formulation of carbidopa-levodopa, which is the standard of care for Parkinson’s disease . The treatment is administered using an infusion pump. The company had applied for FDA approval based on data that demonstrated that ABBV-951 significantly extended the duration of involuntary movement-free periods in patients, compared to orally administered carbidopa-levodopa. Parkinson’s disease is characterized by uncontrollable movements and patients may experience “off” periods after undergoing long-term therapy. AbbVie to resubmit its Marketing Application AbbVie has said that the FDA has not asked for additional efficacy and safety trials and that it plans to resubmit its marketing application as soon as possible. Analysts ...