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Vanda Pharmaceuticals, Inc.

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Mihael H. Polymeropoulos, M.D., president and CEO, announced that a PDUFA date has been set for Fanapt. He stated, "In December of 2015, the FDA accepted for review our sNDA supplemental new drug application for Fanapt for the maintenance treatment of schizophrenia. An FDA PDUFA date has been set for May 2016."
Source: Q4 2015 earnings conference call, 2/10/16

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Vanda Announces FDA Has Accepted for Review the Fanapt® Supplemental New Drug Application for Maintenance Treatment of Schizophrenia in Adults

WASHINGTON, Sept. 15, 2015 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Vanda's filing of a supplemental New Drug Application (sNDA) for Fanapt® seeking approval as a maintenance treatment of schizophrenia in adults.

Vanda is seeking approval based on the results of the REPRIEVE clinical study, which evaluated the long-term maintenance of efficacy and safety of Fanapt®.

The FDA has set a user fee goal date under the Prescription Drug User Fee Act of May 27, 2016, which is the target date for the FDA to complete its review of the sNDA.
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Source: press release, 9/15/15. http://phx.corporate-ir.net/phoenix.zhtml?c=196233&p=irol-newsArticle&ID...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Fanapt (Iloperidone) PsychiatrySchizophreniaAntipsychotic (atypical)5-HT2c serotonin receptor

Mechanism of action: Fanapt (Iloperidone), a SM atypical anti-psychotic, has activity on both dopamine and serotonin receptors with a low binding affinity to the dopamine D2 receptor and high affinity for the 5-HT2 receptor.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-05-27

Results:

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Vanda Announces FDA Approval of the Fanapt® Supplemental New Drug Application for Maintenance Treatment of Schizophrenia in Adults
WASHINGTON, May 26, 2016 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Vanda's supplemental New Drug Application (sNDA) for Fanapt®, modifying and expanding the prescribing information (PI) to describe the effectiveness of Fanapt® as a maintenance treatment for schizophrenia in adults. FDA approval was based on the results of the REPRIEVE (Relapse prevention study in patients with schizophrenia) placebo-controlled clinical study which evaluated the long-term maintenance of efficacy and safety of Fanapt®. The study data submitted in the sNDA came from the REPRIEVE study in which Vanda previously reported 79.6% of patients treated with Fanapt® remained relapse free compared to 36.6% for placebo-treated patients.

The new approved PI now includes placebo-controlled, long-term study data in which Fanapt® was effective in delaying time to relapse in patients with schizophrenia who were stabilized on Fanapt® up to 24 mg/day along with updating the safety section to reflect the larger clinical trial database. Figure 1 from the PI, included below in this press release, contains a Kaplan Meier graph estimating the percent relapse/impending relapse for Fanapt® versus placebo.

The FDA is also currently reviewing Vanda's application for three years marketing exclusivity based upon the REPRIEVE study submission and subsequent PI changes and expansion now approved in the sNDA.
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Source: press release, 5/26/16. http://phx.corporate-ir.net/phoenix.zhtml?c=196233&p=irol-newsArticle&ID...

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