Ferring Pharmaceuticals is set to put its prostate cancer drug Firmagon up against AbbVie's ($ABBV) Lupron in a Phase IIIb trial. The study is designed to assess the cardiovascular safety profile of the gonadotropin-releasing hormone (GnRH) receptor agonist and antagonist, potentially giving Ferring an edge over a product that generated $826 million (€744 million) for AbbVie last year.
|Ferring COO Michel Pettigrew|
Since winning approvals for Firmagon in the U.S. and Europe in 2008 and 2009, respectively, Ferring has suffered a few setbacks in its attempts to gain market share, with FDA chastising the company for overstating its efficacy and the United Kingdom ruling the drug represents poor value for money. Now, Ferring is going back to the clinic in an attempt to generate data to show Firmagon has a better cardiovascular safety profile than Lupron. The trial will enrol 900 patients, give them either Firmagon or Lupron and track major adverse cardiovascular events (MACEs) over the first year of treatment.
Saint-Prex, Switzerland-based Ferring has an inkling that Firmagon will perform well against the primary goal of time from randomization to the first instance of the MACE composite endpoint. Ferring's hunch is backed by data from a hypothesis-generating retrospective analysis of 6 Phase III trials. The study, which Ferring and its collaborators published in European Urology in 2013, linked Firmagon to a significantly lower risk of cardiac events among people with pre-existing conditions than Lupron. Firmagon is a GnRH antagonist, while Lupron is an agonist of the same receptor.
Both drugs are subject to FDA safety notes about their potential effects on people with pre-existing cardiovascular conditions, including congestive heart failure and congenital long QT syndrome. When treating patients with these conditions, FDA recommends physicians consider the risks and benefits before making a decision. If Ferring can show Firmagon is less likely to harm these patients than Lupron, it could lead to it becoming the go-to therapy in this subpopulation of prostate cancer patients.
Such a status was considered when the U.K. assessed the drug, but it found the data too weak. "Because of the uncertainty around both the pooled analyses and the meta-regression analyses presented by the company, and the lack of robust evidence confirming the effect of [Firmagon] on reducing the risk of cardiovascular events compared with [luteinizing hormone-releasing hormone] agonists, it was not possible to conclude that [Firmagon] would reduce the risk of cardiovascular events in people with pre-existing cardiovascular disease," the committee wrote.
- read the statement