(Reuters) – The U.S. Food and Drug Administration (FDA) has declined to approve Amneal Pharmaceuticals’ drug for Parkinson’s disease due to inadequate safety data on the treatment to help control symptoms in patients for a longer duration, the company said on Monday.
The health regulator’s decision is a potential hurdle to the company, which has been looking to grow its portfolio of branded drugs, expecting over $500 million in revenues from its specialty business by 2027.
The FDA in a complete response letter said while the company established the safety of one ingredient, levodopa, based on pharmacokinetic studies, it was not able to adequately establish safety for the other ingredient, carbidopa.
Amneal’s drug is a new formulation of carbidopa-levodopa, the standard of care for Parkinson’s, and is designed in a way that allows it to remain in a certain area of the small intestine for a longer period, helping in its consistent absorption.
The health regulator has requested additional information on the safety of the drug, while no issues on efficacy or manufacturing of the drug were identified.
The company said it will work closely with the health regulator to address the issues and plans to meet with the agency to align on the best path forward.
Parkinson’s is a brain disorder that causes unintended or uncontrollable movements and is the second most-deadly neurodegenerative disease after Alzheimer’s. There is no cure for Parkinson’s currently, but medicines and other therapies can help relieve symptoms.
(Reporting by Raghav Mahobe, Khushi Mandowara and Sriparna Roy in Bengaluru; Editing by Pooja Desai and Shweta Agarwal)
