[Reuters]- The U.S. Food and Drug Administration (FDA) has approved Amnir Pharmaceuticals’ Parkinson’s disease drug due to insufficient safety data on the treatment to help patients control their symptoms long-term. declined, the company said Monday.
Shares of Amnir Pharmaceuticals fell 13.1% to $2.7 in volatile post-market trading.
In its full response letter, the FDA said the company had established the safety of one ingredient, levodopa, based on some studies, but failed to adequately establish the safety of the other ingredient, carbidopa. said.
Health regulators have requested additional information about the drug’s safety, but no issues with its efficacy or manufacturing have been identified.
Amneal’s drug is a new formulation of carbidopa-levodopa, the standard of care for Parkinson’s disease, designed to stay in specific areas of the small intestine longer and aid in consistent absorption.
The company said it is working closely with health regulators and plans to meet with them to address the issue.
The health regulator’s decision poses a potential hurdle for the company as it seeks to expand its portfolio of branded medicines with more than $500 million in revenue from specialty businesses by 2027.
The pharmaceutical company said the decision does not include revenue from the drug and will not affect its 2023 financial forecasts.
Amnir is currently developing another Parkinson’s drug, Writery, which was approved in the market in 2015 but is being used by only 4% of patients, making it difficult to gain a foothold in the therapeutic area. was struggling with
Parkinson’s disease, a brain disorder that causes unintended or uncontrolled movements, is the second deadliest neurodegenerative disease after Alzheimer’s disease. There is currently no cure for Parkinson’s disease, but drugs and other treatments can help relieve symptoms.
(Bengaluru, reported by Raghav Mahobe, Khushi Mandowara and Sriparna Roy; edited by Pooja Desai and Shweta Agarwal)
