FDA accepts sNDA for Vraylar
Application seeks to expand Vraylar label to include Phase III clinical data for the maintenance treatment of schizophrenia.
Allergan has announced that the FDA has accepted for filing the company's supplemental New Drug Application (sNDA) for Vraylar (cariprazine), seeking the addition of new clinical data evaluating Vraylar for the maintenance of efficacy in adults with schizophrenia to the current product label.
"Most patients with schizophrenia are at very high risk of relapse in the absence of antipsychotic treatment," said Dr Herbert Meltzer, Professor of Psychiatry at Northwestern Feinberg School of Medicine. "Without maintenance treatment, 60-70% of patients relapse within one year, and almost 90 relapse within 2 years. These new data show that Vraylar may be a treatment option for the maintenance treatment of schizophrenia."
The data included in the sNDA are from a Phase III multinational, randomized, double-blind, placebo-controlled, parallel-group study of cariprazine in adults with schizophrenia, which found cariprazine compared to placebo significantly delayed the time to relapse. The study included a 20-week open-label phase where patients with schizophrenia were treated with cariprazine 3, 6 or 9 mg per day. Patients who responded and met the stabilization criteria during the open-label period were then randomized to continue their cariprazine dose (3, 6 or 9 mg per day) or switched to placebo for up to 72 weeks or until a relapse occurred. The primary endpoint was time to first symptom relapse during the double blind phase.
Relapse occurred in nearly twice as many placebo- (47.5%) as cariprazine-treated (24.8%) patients. At the end of the double-blind treatment period, analysis of exploratory endpoints also showed a greater mean worsening of symptoms in placebo- vs cariprazine-treated patients on all efficacy parameters as measured by Positive and Negative Syndrome Scale (PANSS) total and subscale scores, the Clinical Global Impressions-Severity (CGI-S) rating scale, the 16-Item Negative Symptom Assessment (NSA-16) and the Personal and Social Performance Scale (PSP) total score. The safety results were consistent with the profile observed to date for cariprazine; no new safety concerns were observed.
"These Phase III data offer additional information about the long-term efficacy and safety of Vraylar for the maintenance treatment of schizophrenia," said David Nicholson, President and EVP, Global R&D at Allergan. "This sNDA filing is part of our commitment to mental health, and we continue to pursue research that will provide physicians and patients with comprehensive information needed to make educated choices regarding treatment options."
Cariprazine was approved by the FDA in September 2015 and is marketed as Vraylar in the US for the acute treatment of manic or mixed episodes of Bipolar I Disorder and the treatment of Schizophrenia in adults.
Related News
-
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute. -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance