Vanda Pharmaceuticals (VNDA) sNDA for Fanapt Approved by U.S. FDA for Schizophrenia

May 26, 2016 4:33 PM EDT

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Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) 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.

REPRIEVE Study Results SummaryThe REPRIEVE study was a randomized, double-blind, placebo-controlled study to evaluate prevention of relapse in adult patients with schizophrenia receiving either flexible dose Fanapt® or placebo. Study subjects were adults with schizophrenia titrated up to 12 mg/day given as 6 mg BID (twice daily) with open-label Fanapt® and then stabilized for a further 14 to 24 weeks with a flexible dose Fanapt® regimen (range between 8 and 24 mg/day daily dose given BID) as per investigator judgment. Subjects who remained clinically stable for at least 12 weeks entered the "Relapse Prevention" phase and were randomized 1:1 to either continue on the same flexible dose regimen of Fanapt® or to withdraw from Fanapt® to matched placebo in a double-blinded fashion. Subjects were followed for up to 26 weeks and were withdrawn upon showing signs of relapse or impending relapse. A predefined unblinded interim analysis was conducted after 68 relapse or impending relapse events were observed. The primary outcome was time-to-relapse or impending relapse using the interim analysis population.

Of the 587 patients entering the "Stabilization" phase, 195 (33%) met the criteria for the double-blind Relapse Prevention phase, with 99 subjects randomized to continue with Fanapt® and 96 to switch to placebo. The study was stopped early after 68 events were observed and confirmed the hypothesis that Fanapt® was more effective than placebo in relapse preventions (log rank test: P < .0001), with a Cox regression hazard ratio estimate of 4.7 (95% confidence interval: 2.7-8.3) favoring Fanapt®. The percentage of Fanapt® patients remaining relapse free at the end of the double-blind Relapse Prevention phase was of 79.6% (the Kaplan-Meier estimate (KM estimate)) compared to 36.6% for placebo-treated patients. The mean time to relapse based on KM estimates was 71 days for placebo and 139 days for Fanapt® subjects. The most common adverse events (AEs) (>= 5%) suspected to be related to Fanapt® in the stabilization phase were dizziness, sleepiness and dry mouth. There were no Fanapt® AEs with a frequency >2% and higher than placebo in the double-blind Relapse Prevention phase.

Figure 1:

Kaplan Meier Estimation of Percent Relapse/Impending Relapse for iloperidone (Ilo) and placebo (Pbo)



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