The U.S. Food and Drug Administration (FDA) has recently declined to approve a drug developed by Amneal Pharmaceuticals for the treatment of Parkinson's disease. The FDA rejected the drug primarily due to concerns regarding insufficient safety data. Following the announcement, Amneal Pharmaceuticals' shares experienced a significant drop of 14.8% during after-market trading.
In its complete response letter, the FDA requested additional data to ensure the safety of one of the drug's components, carbidopa. Although previous studies have demonstrated the safety of the other component, levodopa, the agency was not convinced about the overall safety profile of the drug. However, the FDA did not identify any issues related to the drug's efficacy or manufacturing process.
This drug is a new formulation of carbidopa-levodopa, which is considered the standard of care for Parkinson's disease. The innovative formulation aims to enable the drug to stay in the small intestine for a longer duration, ensuring consistent absorption and better symptom control in patients.
Amneal Pharmaceuticals has expressed its commitment to working closely with the FDA to address the safety concerns outlined in the complete response letter. This unexpected decision is likely to delay the drug's potential launch until at least the first half of 2024, according to Barclays analyst Balaji Prasad.
Amneal had high expectations for the drug, as it hoped to generate over $500 million in revenues from its specialty business by 2027. However, the rejection does not impact the company's 2023 forecast, as it had not included revenue from this particular drug in its projections.
Notably, Amneal Pharmaceuticals already has another Parkinson's drug called Rytary on the market. However, the company has struggled to gain significant traction in the treatment space, with only approximately 4% of patients currently using the drug since its approval in 2015, according to the company's estimates.
Parkinson's disease is a chronic brain disorder that leads to involuntary or uncontrolled movements. It is the second most-deadly neurodegenerative disease after Alzheimer's. While there is currently no cure for Parkinson's, medication and various therapies are available to help alleviate symptoms and improve patients' quality of life.