Following positive data from two Phase III clinical trials of lurasidone HCl in bipolar depression, Sunovion is eager to capture a large patient share by seeking approval for Latuda as both a mono and adjuvant therapy. While Sunovion will be competing with AstraZeneca's Seroquel franchise, Latuda's efficacy in alleviating cognitive symptoms offers potential for differentiation.
The FDA has accepted for review two supplemental New Drug Applications (sNDAs) for the use of Sunovion's Latuda (lurasidone HCI) as monotherapy and adjunctive therapy (to lithium or valproate) to treat adult patients with depressive episodes associated with bipolar I disorder. This step towards indication expansion follows the EMA's recent acceptance of Takeda's Marketing Authorization Application for Latuda in schizophrenia. Sunovion initially launched Latuda in the US in February 2011 for the treatment of schizophrenia.
Sunovion's sNDAs included data from two 6-week, double-blind, placebo-controlled Phase III trials that involved a total of 852 patients with bipolar depression. PREVAIL 1 and 2 (Program to Evaluate the Antidepressant Impact of Lurasidone) studied the efficacy and safety of lurasidone HCl as a monotherapy and adjuvant therapy, respectively. In addition to significant reductions with lurasidone therapy compared to placebo in the primary endpoint of the Montgomery-Asberg Depression Rating Scale, the company reported statistically higher responder rates and significant reductions in anxiety symptoms, as well as significant improvements in quality of life. In view of the FDA's approval of Latuda for the treatment of schizophrenia, and the drug's well-established safety and tolerability profile - which boasts a minimal extrapyramidal symptom risk and minimal effect on weight and lipid profile - the FDA's verdict on use of Latuda in bipolar disorder will be dependent on the agency's opinion of Latuda's efficacy. Datamonitor expects the FDA to grant approval of Latuda as a treatment for bipolar depression in Q4 2013.
Sunovion's decision to seek approval of Latuda as a treatment for bipolar disorder represents a commonly pursued indication expansion strategy in the psychiatry market. However, in developing Latuda for the treatment of bipolar I depression, Sunovion is targeting one of the most pressing unmet needs in the management of bipolar disorder: improved therapies for the treatment of the depressive phase. The depressive phase of bipolar disorders dominates the long-term course of the disease and, currently, only three products are approved for this phase: Seroquel, Seroquel XR (quetiapine; AstraZeneca), and Symbyax (fluoxetine/olanzapine; Eli Lilly).
Sunovion is aiming to maximize its patient share by seeking approval for Latuda as both a monotherapy and adjuvant therapy. The company has recognized that lithium and valproate are key first-line treatment options for bipolar depression, and aims to position Latuda alongside these therapies. Upon approval, Latuda will therefore serve to expand the range of treatment options for the 4 million individuals estimated to suffer from bipolar disorder in the US in 2012.
As an atypical antipsychotic, Latuda's "me-too" mechanism of action is likely to hinder its ability to compete with established branded antipsychotics and their generic counterparts in bipolar depression. In particular, the product will face strong competition from AstraZeneca's Seroquel franchise (and generic quetiapine), which Datamonitor regards as the modern day gold-standard treatment for bipolar disorder. Nevertheless, in preclinical models studying the effect of atypical antipsychotics in improving cognition, lurasidone has been found to be the superior atypical antipsychotic. Accordingly, with evidence for improvements in the quality of life of patients, further investigation into the impact of Latuda on the cognitive symptoms of bipolar disorders could provide Sunovion with the opportunity to achieve product differentiation. Indeed, the cognitive symptoms of bipolar disorder are increasingly being recognized by physicians as a key unmet need, affecting an estimated 26-64% of bipolar disorder patients.