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Neurocrine Biosciences, Inc.

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Neurocrine Announces INGREZZA™ (valbenazine) New Drug Application for the Treatment of Tardive Dyskinesia has been Accepted for Priority Review by U.S. FDA
SAN DIEGO, Oct. 11, 2016 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for INGREZZATM (valbenazine) for the treatment of tardive dyskinesia. The INGREZZA application has been given a Prescription Drug User Fee Act (PDUFA) target action date of April 11, 2017.

"This is another significant milestone for Neurocrine and more importantly those patients who are suffering from tardive dyskinesia," said Kevin C. Gorman, President and Chief Executive Officer of Neurocrine Biosciences. "We will continue to work with the FDA in their review of the INGREZZA NDA to potentially bring this important treatment option to patients and physicians."

A Priority Review designation accelerates the FDA review timeline from 10 months to 6 months from the date of acceptance of the NDA. The designation directs the FDA's overall attention and resources to the evaluation of applications for drugs that, if approved, would be a significant improvement in the safety or effectiveness of the treatment of a serious condition. INGREZZA (valbenazine) previously received Fast Track status and Breakthrough Designation status from the FDA.

The NDA for INGREZZA includes the results from the Kinect 2 and Kinect 3 clinical trials which evaluated over 330 tardive dyskinesia patients. Data from these studies along with the results from another 18 clinical trials, extensive preclinical testing and drug manufacturing data were included in the NDA submission.
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Source: press release, 10/11/16. http://phx.corporate-ir.net/phoenix.zhtml?c=68817&p=irol-newsArticle&ID=...

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Neurocrine Submits New Drug Application for Valbenazine for Treatment of Tardive Dyskinesia
SAN DIEGO, Aug. 29, 2016 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-daily dosing of valbenazine in treating tardive dyskinesia.

"This is an important milestone in the development of valbenazine for the treatment of tardive dyskinesia, a serious disease for which there is no FDA approved pharmaceutical treatment," said Kevin C. Gorman, President and Chief Executive Officer of Neurocrine Biosciences. "We look forward to working with the FDA in their review of the valbenazine NDA submission to potentially bring this important treatment option to patients and physicians."

The NDA for valbenazine includes the results from the Kinect 2 and Kinect 3 clinical trials which evaluated over 330 tardive dyskinesia patients. Data from these studies along with the results from another 18 clinical trials, extensive preclinical testing and drug manufacturing data were included in the NDA submission. The Company expects to receive notification of the acceptance of the NDA, as well as the timeframe for NDA review from the FDA in October 2016.
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Source: press release, 8/29/16. http://phx.corporate-ir.net/phoenix.zhtml?c=68817&p=irol-newsArticle&ID=...

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During the fourth quarter of 2015, the Company announced positive top-line results from the Kinect 3 study, a Phase III trial that included moderate to severe tardive dyskinesia in patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder. The Kinect 3 study randomized 234 subjects to either placebo, once-daily 40mg of NBI-98854 (valbenazine), or once-daily 80mg of valbenazine for six weeks of placebo-controlled dosing followed by an extension of active dosing through Week 48. The primary efficacy endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at Week 6 in the 80mg once-daily dosing group compared to placebo as assessed by central blinded video raters. The AIMS ratings at Week 6 for the 80mg once-daily valbenazine intention-to-treat (ITT) population was reduced 3.1 points (Least-Squares Mean) more than placebo (p<0.0001). During the six-week placebo-controlled treatment period valbenazine was generally well tolerated. The frequency of adverse events was similar among all treatment groups and treatment emergent adverse effects were consistent with those of prior studies.

In addition to the ongoing safety assessment of Kinect 3, the Company is also conducting a separate one-year open-label safety study of valbenazine, Kinect 4, to support the anticipated 2016 filing of a New Drug Application of valbenazine in tardive dyskinesia. As announced previously, Neurocrine has received Breakthrough Therapy Designation from the FDA for valbenazine in the treatment of tardive dyskinesia.
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Source: press release, 2/11/16

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Valbenazine (NBI-98854) Tardive DyskinesiaPsychiatryTardive DyskinesiaVMAT2 inhibitorVMAT2

Mechanism of action: Valbenazine (NBI-98854) is a potent, highly selective, VMAT2 inhibitor that is effective in regulating the levels of dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2017-04-11

Results: Pending