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Alkermes Gets FDA Approval for ARISTADA INITIO for Schizophrenia

It was a day of celebration on Monday for Alkermes (NASDAQ:ALKS) when the fully integrated, global biopharmaceutical company announced that the United States Food and Drug Administration has approved the company’s ARISTADA INITIO™ for the initiation of ARISTADA® (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults.

Schizophrenia is a complex, chronic, and severe mental disorder that affects how a person thinks, feels, and behaves. The disorder is characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions.

According to, approximately 3.5 million people in the United States are diagnosed with schizophrenia and it is one of the leading causes of disability. Three-quarters of persons with schizophrenia also develop the illness between 16 and 25 years of age.

This approval of Aristada Initio makes Aristada the first and only long-acting atypical antipsychotic that can be initiated on day one and gives physicians an alternative regimen to initiate patients onto any dose of ARISTADA on day one.

Prior to this, the standard regimen included being dosed with Aristada for 21 consecutive days once the first dose started.

Chief Executive Officer as well as Principal Investigator of the Collaborative Neuroscience Network, David Walling, Ph.D., commented, “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. 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. This supports continuity of care for patients and allows the care team to focus their efforts on other aspects of the treatment paradigm that contribute to long-term positive outcomes.”

“Long-acting injectable atypical antipsychotics have an increasingly recognized role in the treatment of schizophrenia. The ability to initiate ARISTADA on day one may be particularly useful in the hospital setting, where more than one-third of patients initiate onto long-acting therapies,” remarked Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes.

He added, “The approval of ARISTADA INITIO adds an important new option to our growing schizophrenia portfolio and reaffirms Alkermes’ commitment to developing innovative treatments that address the real-world needs of people living with schizophrenia.”

ARISTADA INITIO is expected to be available in mid-July.

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