An AcelRx drug for Alzheimer’s patients that can be used for five years, and has been approved for use in India has been made available in the country.
An approval of Acelrx for Alzheimer and Parkinson’s disease (AD/PD) and Parkinson-like disorder (PLD) was issued by the Food and Drug Administration (FDA) on Monday.
The drug, called cetirizumab, is manufactured by Acel Research and has received approval from the National Institute of Health.
It is designed to target the central nervous system (CNS) and is a derivative of a drug called cefixime.
The FDA also said the approval of the drug for AD/PD was the first for Acel, which had been approved in April 2017 by the World Health Organization (WHO).
The approval for Parkinson’s is expected soon.
Acel’s co-founder and chief executive, Srinivasan Srinivasa Reddy, said the company was delighted with the announcement.
“We are thrilled to be able to deliver a first-class product that has been clinically proven in a large population to be safe, effective and safe for human clinical trials,” he said in a statement.
Acel has been operating in India since 2004 and has produced the drug in India.
A new version of the cetralizumib is scheduled to be approved by the Indian government on August 10.
According to the FDA, Acel’s approval comes as a result of extensive studies on the drug’s safety, efficacy and potential to extend life.
It said the FDA approved the drug based on “all relevant information available at the time” and noted that there was no evidence that the drug would have adverse effects in the clinical trials in India in which the drug is currently being tested.
The drug has been manufactured by India’s Acel Pharma, which was founded in 1996.
A previous version of Acell was approved in India by the FDA in 2005.
A Celrx spokesperson did not immediately respond to a request for comment.