en years after the FDA first rejected SHP465 it is back in front of the regulators with a decision due by June 20. With new clinical data under its beltSHP465 will be needed to expand Shire’s ADHD franchise (see table below).
Also results are due mid-year for Abbvie’s Venclexta in chronic lymphocytic leukaemia. Already approved in a subset of patients the data could lead to an expanded label and offer a welcome revenue stream as the pressure from biosimilars approaches.
Decade later
SHP465 was originally before the regulators back in 2007 but additional trials were requested. Now the resubmission includes data from studies in paediatric patients (aged 6-17) and adult patients with ADHD.
After its setback SHP465 sat on the shelf until 2014 when Shire decided to start a new trial just five days before Abbvie’s takeout bid. The reasons for freezing and resuscitating the project aren’t clear but with forecast sales of $416m by 2022, according to consensus from EvaluatePharma, it is expected to be Shire’s sixth biggest growth driver.
The strength of SHP465 comes in its long duration; it is a once-daily treatment while otherADHD drugs are given more frequently. Shire hopes this will allow patients to stop using both an immediate and extended-release version of Adderall to achieve the same control. WhileSHP465 isn’t expected to reach the blockbuster numbers of Adderall or Vyvanse its last patent expires in 2029, six years after Vyvanse loses market exclusivity (More than ever Shire needs unusual focus on ADHD franchise, June 30, 2016).
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