Proactive Investors - Run By Investors For Investors

Alkermes Plc gets a boost as FDA approves its injectable schizophrenia drug

ARISTADA INITIO is expected to hit the market later this month
Needle
Alkermes shares are up nearly 7% in pre-market trade on the news

Alkermes Plc (NASDAQ:ALKS) reported a dose of good news, with today’s announcement that the US Food and Drug Administration has given the go-ahead and approved ARISTADA INITIO, its long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults.

ARISTADA INITIO (aripiprazole lauroxil), which is taken with a single 30mg dose of oral aripiprazole, is expected to hit the market this month.

“The approval of ARISTADA INITIO makes ARISTADA the first and only long-acting atypical antipsychotic that can be initiated on day one, representing an important addition to the treatment paradigm for the complex illness of schizophrenia,” said Dr. David Walling, chief executive and principal investigator of the Collaborative Neuroscience Network.

“For physicians and caregivers alike, the ARISTADA INITIO regimen provides a level of confidence that patients can walk out the door with up to two months of coverage with a proven medication in their system,” Walling added.

Schizophrenia is a chronic and disabling disorder, which involves hallucinations, delusions, depression and social withdrawal. As many as 2.4mln American adults have schizophrenia.

Alkermes shares climbed 6.85% to US$43.98 on the announcement of the drug’s approval.

View full ALKS profile View Profile

Alkermes Timeline

Related Articles

Scientist
December 03 2018
Since September, the group's portfolio has steamed ahead with a number of new and successful clinical trials, as well as a boost from the float of one of its companies on the Nasdaq
Nemaura Medical Inc CEO Dr Faz Chowdhury
November 06 2018
The medtech company is eying explosive growth with sugarBEAT, on the cusp of launching in the UK, followed by the rest of Europe in 2018
myLotus testing kit
October 31 2018
The launch at the Fertility Show in London at the start of November is the first step in a switch in focus brought about by new executive chairman Matthew Walls

© Proactive Investors 2019

Proactive Investors Australia PTY LTD ACN:132787654 ABN:19132787654.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use