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FDA approval of Lundbeck and Otsuka Pharmaceuticals Rexulti - which was announced last week - delivers a third atypical antipsychotic to the US market for the treatment of both schizophrenia and major depressive disorder (MDD).
Rexulti will not only compete with Abilify and Seroquel XR, but generic versions of the former - the branded also marketed by Otsuka - which have been available since US patent expiration in April. While FDA approval of Rexulti in both schizophrenia and MDD with similar labelling to competitors frames a "best case scenario" for the drug, remarked analysts at Jefferies, questions remain as to whether Lundbeck and Otsuka can sufficiently differentiate Rexulti from these competitors.
With Rexulti positioned as a successor to Abilify, Otsuka expects blockbuster sales to be achieved. The size of the US market for schizophrenia and MDD therapies, coupled with demand for new approaches to treatment, are supportive of such aspirations, suggest analysts at Credit Suisse. In a note to investors detailing approval of Rexulti last week, analysts at Deutsche Bank indicated that an improved tolerability profile versus Abilify could provide the best opportunity for Rexulti to emerge from the shadow of competition.
Given the size of the market, added analysts at Jefferies, "while Rexulti may struggle to compete with established market-leading brands, if a new drug is able to become a second or third-line alternative and capture a small share of the market it could generate blockbuster revenues."
To better assess the pending launch of Rexulti in the US market, FirstWord is polling US-based psychiatrists and primary care practitioners with the following questions
- Based on pivotal-stage data (http://investor.lundbeck.com/releasedetail.cfm?
ReleaseID=921621), what is your assessment of Rexultis (brexpiprazole) clinical profile?
- Based on the same data, do you believe Rexulti is differentiated from Abilify and Seroquel XR?
- Based on the same data, what is your assessment of Rexultis tolerability profile versus existing atypical antipsychotics approved for major depressive disorder and schizophrenia?
- Factoring in the recent availability of generic Abilify in what line of therapy would you most likely use Rexulti for the treatment of schizophrenia?
- Factoring in the recent availability of generic Abilify in what line of therapy would you most likely use Rexulti for the treatment of major depressive disorder?
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