Allergan's (AGN) Vraylar Gets RTF From FDA, New Data For CVC

Allergan plc (NYSE:AGN) announced that the FDA has issued a refusal-to-file (RTF) letter to its supplemental New Drug Application (sNDA) for Vraylar (cariprazine). The company is looking to get Vraylar’s label expanded to include new data, which supports the drug’s use as a maintenance treatment.

Vraylar is presently approved in Europe for treatment of schizophrenia.

Allergan’s share price is down 2.5% this year so far, comparing favorably with the industry’s decrease of 22.3%.

The FDA said that the sNDA was not sufficiently complete to allow a substantive review. The company plans to meet the FDA officials to understand what additional information will be required.

We remind investors that earlier in March, the FDA had accepted the company’s sNDA for Vraylar. The sNDA was based on data from a phase III study, evaluating Vraylar for maintenance of efficacy in adults with schizophrenia. Data from the study showed that Vraylar has significantly delayed the time to relapse compared with placebo. Also, relapse occurred in nearly twice as many placebo patients (47.5%) in comparison to those treated with Vraylar.

Vraylar has performed above expectations in 2016, recording sales of $94.3 million in the year. The drug is likely to be a key driver of Allergan’s top-line growth in 2017.

Other players in the bipolar disorder and schizophrenia treatment market include AstraZeneca plc’s (NYSE:AZN) Seroquel XR, Johnson & Johnson’s (NYSE:JNJ) Risperdal Consta and Alkermes plc’s (NASDAQ:ALKS) Aristada.

In a separate press release, Allergan announced new data from the CENTAUR phase IIb study, evaluating its pipeline candidate cenicriviroc (CVC) for treating liver fibrosis in adult patients with NASH.

These phase IIb data supports continued development of cenicriviroc (CVC) in the ongoing phase III AURORA study evaluating the safety and efficacy of the candidate for liver fibrosis in adult patients with NASH.

The CENTAUR study demonstrated no significant difference in fibrosis improvement being observed between CVC and placebo in the second year for patients administered with CVC for a couple of years. Some patients switched over to CVC in year two after remaining on placebo for a year. 20% of such patients receiving CVC achieved the combined endpoint of reduction in fibrosis by at least one stage with no worsening of NASH. This find lies in straight comparison to 13% of those remaining on placebo.

Zacks Rank

Allergan currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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